Gene Therapy Clinical Trials

  • A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

    This is a phase II, multi-center, open-label, five-arm study in which the efficacy andsafety of oral ceritinib treatment will be assessed in patients with NSCLC metastatic to thebrain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDAapproved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoringalgorithm (including positivity criteria). If documentation of ALK rearrangement asdescribed above is not locally available, a test to confirm ALK rearrangement must beperformed by a Novartis designated central laboratory. Patients must wait for the centrallaboratory result of the ALK rearrangement status before initiating treatment withceritinib.

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  • Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma

    High Grade Gliomas, including anaplastic astrocytomas, anaplastic oligodendrogliomas andglioblastomas (GBM), are the most common and most aggressive primary brain tumors. Prognosisfor patients with high-grade gliomas remains poor. The estimated median survival forpatients with GBM is between 12 to 18 months. Recurrence after initial therapy withtemozolomide and radiation is nearly universal. Since May 2009, the majority of patients inthe US with an initial recurrence of high-grade glioma receive bevacizumab, a monoclonalantibody against vascular endothelial growth factor (VEGF), which is thought to preventangiogenesis in these highly vascular tumors. BEV has response rates from 32-62% and hasimproved overall median survival in patients with recurrent high-grade gliomas1. However,the response is short lived, and nearly 100% of patients eventually progress despitebevacizumab. No chemotherapeutic agent administered following progression throughbevacizumab has made a significant impact on survival. Patients progress to death within 1-5months after resistance develops. Therefore, patients with high-grade gliomas who haveprogressed through bevacizumab represent a population in dire need of a feasible andtolerable treatment.

    NKTR-102 is a topoisomerase I inhibitor polymer conjugate that was engineered by attachingirinotecan molecules to a polyethylene glycol (PEG) polymer using a biodegradable linker.Irinotecan released from NKTR-102 following administration is further metabolized to theactive metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38), that causes DNA damage throughinhibition of topoisomerase. The goal in designing NKTR-102 was to attenuate or eliminatesome of the limiting side effects of irinotecan while improving efficacy by modifying thedistribution of the agent within the body. The size and structure of NKTR-102 results inmarked alteration in pharmacokinetic (PK) profile for the SN38 derived from NKTR-102compared to that following irinotecan: the maximal plasma concentration (Cmax) is reduced 5-to 10-fold and the half-life (t1/2 ) of SN38 is increased from 2 days to approximately 50days. This altered profile leads to constant exposure of the tumor to the active drug. Inaddition, the large NKTR-102 molecule does not freely pass out of intact vasculature, whichmay account for relatively higher concentrations of the compound and the active metabolitesin tumor tissues in in vivo models, where the local vasculature may be relatively morepermeable. A 145 mg/m2 dose of NKTR-102, the dose intended for use in this phase II clinicaltrial (and being used in the phase III clinical program), results in approximately the sameplasma exposure to SN38 as a 350 mg/m2 dose of irinotecan, but exposure is protracted,resulting in continuous exposure between dosing cycles and lower Cmax. NKTR-102 wastherefore developed as a new chemotherapeutic agent that may improve the clinical outcomesof patients.

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  • A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma

    This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluatethe safety and efficacy of onartuzumab (MetMAb) in combination with bevacizumab as comparedto bevacizumab alone and of onartuzumab as monotherapy in patients with recurrentglioblastoma. Patients will be randomized 1:1:1 to receive either placebo plus bevacizumabevery 3 weeks, or onartuzumab plus bevacizumab, or onartuzumab plus placebo. Anticipatedtime on study treatment is until disease progression or unacceptable toxicity occurs.

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  • A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

    The purpose of this research study is to find out whether adding an experimental vaccinecalled rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab canimprove progression free survival (slowing the growth of tumors) of patients with relapsedEGFRvIII positive glioblastoma.

    Investigator

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  • Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases

    This randomized phase III trial compares memantine hydrochloride and whole-brainradiotherapy with or without hippocampal avoidance in reducing neurocognitive decline inpatients with cancer that has spread to the brain. Whole brain radiotherapy (WBRT) is themost common treatment for brain metastasis. Unfortunately, the majority of patients withbrain metastases experience cognitive deterioration after WBRT. Memantine hydrochloride mayenhance cognitive function by binding to and inhibiting channels of receptors located in thecentral nervous system. Radiation therapy uses high energy x-rays to kill tumor cells andshrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoidthe hippocampal region during WBRT, may reduce the radiation dose to the hippocampus andhelp limit the radiation-induced cognitive decline. It is not yet known whether givingmemantine hydrochloride and WBRT with or without hippocampal avoidance works better inreducing neurocognitive decline in patients with brain metastases.

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  • A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)

    A Phase 1b/2, multicenter, open-label study designed to evaluate the efficacy and safety ofACP-196 in subjects with recurrent GBM who have progressed after 1 or 2 prior systemictreatment regimens.

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  • Ixazomib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

    This phase II trial studies how well ixazomib works in treating patients with relapsed orrefractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells by blockingsome of the enzymes needed for cell growth.

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  • Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkins Lymphoma

    The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe andtolerable when they are given together.

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  • A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

    The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapyresults in a clinically significant improvement in progression free survival (PFS) ascompared to treatment with ofatumumab in patients with relapsed or refractory ChronicLymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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  • Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

    This is a randomized double blind placebo controlled study of azacitidine with or withoutbirinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS ormyelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical andmechanistic studies support that azacitidine may modulate pathways that enablebirinapant-mediated anti-tumor activity.

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  • TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy

    The purpose of this study is to compare the anti-tumor efficacy of oral single-agentrociletinib, as measured by investigator assessment of the PFS, with that of single-agentcytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC afterfailure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containingdoublet chemotherapy.

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  • A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors

    To determine the maximum tolerated dose or optimal biological dose, and the safety profileof MEDI3617 when given as a single-agent or in combination with other chemotherapeuticagents in subjects with advanced solid malignancies resistant to standard therapy.

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  • A Phase 1/2 Study to Evaluate MEDI4736

    This is a multicenter, open-label, first-time-in-human study with a standard 3+3dose-escalation phase in subjects with advanced solid tumors followed by an expansion phasein patients with advanced solid tumors. An exploration cohort has been added to determinethe safety using Q4W dosing.

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  • Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes

    This randomized phase II trial studies how well donor umbilical cord blood transplant withor without ex-vivo expanded cord blood progenitor cells works in treating patients withacute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, ormyelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donorumbilical cord blood transplant helps stop the growth of cancer cells. It may also stop thepatient's immune system from rejecting the donor's cells. When the healthy stem cells andex-vivo expanded cord blood progenitor cells are infused into the patient they may help thepatient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Itis not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expandedcord blood progenitor cells is more effective than giving a donor umbilical cord bloodtransplant alone.

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  • Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

    The purpose of this study is to collect safety and performance data of the Photodynamic BoneStabilization System (PBSS) when used for the treatment of painful impending and actualfractures of the humerus secondary to metastatic cancer.

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  • Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)

    This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a DoseEscalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004will be administered by IV infusion once weekly as part of a 21-day dosing cycle.

    Investigator

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  • 18F FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly Diagnosed or Recurrent Gliomas

    This clinical trial compares fluorine F 18 fluorodopa (18F FDOPA) positron emissiontomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors inpatients with glioma that is newly diagnosed or recurrent (has returned). 18F FDOPA is aradioactive drug that binds to tumor cells and is captured in images by PET. Computedtomography (CT) and MRI are used with PET to describe information regarding the function,location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI inhelping doctors find and measure brain tumors.

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  • Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

    This pilot phase I/II trial studies the side effects and best dose of plerixafor afterradiation therapy and temozolomide and to see how well it works in treating patients withnewly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blockingblood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in differentways to stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixaforafter radiation therapy and temozolomide may be an effective treatment for high gradeglioma.

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  • Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

    This study will evaluate the effect of treatment with idelalisib (IDELA) plus rituximab onoverall response rate (ORR); onset, magnitude, and duration of disease control (includingduration of response [DOR], progression free survival [PFS], and overall survival [OS]); andminimal residual disease (MRD) in subjects with previously untreated chronic lymphocyticleukemia (CLL) with 17p deletion. In addition, the study will evaluate the safety profileobserved with the combination of IDELA and rituximab.

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  • A Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (RESONATE™-2)

    A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine KinaseInhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naiveChronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

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  • An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI-32765 Versus Chlorambucil)

    An Open-label Extension Study in Patients 65 Years or Older with Chronic LymphocyticLeukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA(PCI-32765 versus Chlorambucil)

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  • A Phase 1 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

    This Phase I, multicenter, first in human, open-label, dose escalation study will evaluatethe safety, tolerability, and pharmacokinetics of Atezolizumab administered as single agentby intravenous (IV) infusion to patients with locally advanced or metastatic solidmalignancies or hematologic malignancies.

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  • A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome

    This study will assess the safety and efficacy of vismodegib in patients withrelapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-riskmyelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib150 mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily incombination with cytarabine 20 mg subcutaneously for 10 days.

    Anticipated time on study treatment is until disease progression, intolerable toxicity, orpatient withdrawal of consent.

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  • An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects

    The primary objective of the study is to determine whether quizartinib monotherapy prolongsoverall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosinekinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or haverelapsed within 6 months, after first-line AML therapy.

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  • S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancercells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells andhelp kill them or carry cancer-killing substances to them. Others interfere with the abilityof cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocyticleukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combinationchemotherapy may be more effective in treating promyelocytic leukemia.

    PURPOSE: This phase II trial is studying how well giving gemtuzumab together withcombination chemotherapy works in treating patients with previously untreated promyelocyticleukemia.

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  • Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

    This randomized phase III trial studies combination chemotherapy with blinatumomab to seehow well it works compared to induction chemotherapy alone in treating patients with newlydiagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase(ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work indifferent ways to stop the growth of cancer cells, either by killing the cells, by stoppingthem from dividing, or by stopping them from spreading. Monoclonal antibodies, such asblinatumomab, may block cancer growth in different ways by targeting certain cells. It isnot yet known whether combination chemotherapy is more effective with or withoutblinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

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  • Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

    Study to compare efficacy and safety of oral Azacitidine plus best supportive care versusbest supportive care as maintenance therapy in Subjects with Acute Myeloid Leukemia (AML),age = or >55 years, who have achieved first complete remission (CR) or complete remissionwith incomplete blood count recovery (CRi) after induction with intensive chemotherapy withor without consolidation chemotherapy.

    Investigators

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  • An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

    This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients withhematologic malignancies who complete other idelalisib studies. It provides the opportunityfor patients to continue treatment as long as the patient is deriving clinical benefit.Patients will be followed according to the standard of care as appropriate for their type ofcancer. The dose of idelalisib will generally be the same as the dose that was administeredat the end of the prior study, but may be titrated up to improve clinical response or downfor toxicity. Patients will be withdrawn from the study if they develop progressive disease,unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit inthe opinion of the investigator.

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  • Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

    This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostatgiven 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination withinduction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with acytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety ofthe combination in this regimen.

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  • Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

    This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine inthe hopes of finding a treatment that may be effective against Acute Myeloid Leukemia thathas come back after treatment.

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  • A Study Being Conducted at Multiple Locations to Compare the Safety and Effectiveness of Three Different Treatment Regimens; 1) Lenalidomide, 2) Lenalidomide + Azacitidine, or 3) Azacitidine Alone in Newly Diagnosed Acute Myeloid Leukemia in Elderly Subjects ≥ 65 Years of Age

    The aim of the study is to investigate the effect of a lenalidomide regimen, a sequentialazacitidine plus lenalidomide regimen or an azacitidine regimen in elderly subjects 65 yearsor older with newly diagnosed AML.

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  • Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

    The purpose of this study is to determine the safety and effectiveness of pracinostat whencombined with azacitadine for patients who are 65 years of age or older and have AcuteMyelogenous Leukemia (AML)

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  • Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

    This phase II trial is studying the side effects of giving combination chemotherapy togetherwith or without donor stem cell transplant and to see how well it works in treating patientswith acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stopthe growth of cancer cells, either by killing the cells or by stopping them from dividing.Giving more than one drug (combination chemotherapy) may kill more cancer cells. Givingchemotherapy and total-body irradiation before a donor stem cell transplant helps stop thegrowth of cancer cells. It also stops the patient's immune system from rejecting the donor'sstem cells. The donated stem cells may replace the patient's immune cells and help destroyany remaining cancer cells (graft-versus-tumor effect).

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  • S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia

    This phase I trial studies the side effects and best dose of inotuzumab ozogamicin whengiven together with combination chemotherapy in treating patients with relapsed orrefractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancercells that express cluster of differentiation (CD)22 and kill them without harming normalcells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, andprednisone, work in different ways to stop the growth of cancer cells, either by killing thecells or by stopping them from dividing. Giving inotuzumab ozogamicin together withcombination chemotherapy may kill more cancer cells.

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  • Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

    This study will evaluate the safety and clinical activity of idelalisib in combination withan anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an mTOR inhibitor, aprotease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent inparticipants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantlecell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).

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  • S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

    RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in differentways to stop the growth of cancer cells, either by killing the cells or by stopping themfrom dividing. Pravastatin may stop the growth of cancer cells by blocking some of theenzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine workbetter by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabinetogether with pravastatin may kill more cancer cells.

    PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine togetherwith pravastatin works in treating patients with relapsed acute myeloid leukemia.

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  • Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

    This randomized phase III trial studies rituximab with bendamustine hydrochloride oribrutinib to see how well they work compared to ibrutinib alone in treating older patientswith previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such asrituximab, may block cancer growth in different ways by targeting certain cells. Drugs usedin chemotherapy, such as bendamustine hydrochloride, work in different ways to stop thegrowth of cancer cells, either by killing the cells, by stopping them from dividing, or bystopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking someof the enzymes needed for cell growth. It is not yet known whether rituximab withbendamustine hydrochloride is more effective than rituximab and ibrutinib or ibrutinib alonein treating chronic lymphocytic leukemia.

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  • Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer

    This pilot clinical trial studies imaging during surgery in diagnosing patients withprostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,bladder, or kidney cancer

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  • Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)

    The study is designed as a Phase III, randomized, open label, multicenter, prospective,comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheralblood stem cells (PBSC) versus marrow from unrelated donors for transplantation in patientswith hematologic malignancies. Recipients will be stratified by transplant center anddisease risk and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.

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  • Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

    To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronicmyelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).

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  • Genome, Proteome and Tissue Microarray in Childhood Acute Leukemia

    We will study gene and protein expression in leukemia cells of children diagnosed with acuteleukemia. We hope to identify genes or proteins which can help us grade leukemia atdiagnosis in order to: (a) develop better means of diagnosis and (b) more accurately choosethe best therapy for each patient.

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  • Determine Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell ALL

    This is a single arm, open-label, multi-center, phase II study to determine the efficacy andsafety of CTL019 in pediatric patients with r/r B-cell ALL.

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  • Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

    This is a single arm, open-label, multi-center, phase II study to determine the efficacy andsafety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cellacute lymphoblastic leukemia, who are chemo-refractory, relapsed after allogeneic SCT, orare otherwise ineligible for allogeneic stem cell transplant.

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  • A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

    This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacyand safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL afterB-cell receptor signaling pathway inhibitors (BCR PI) treatment.

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  • Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

    RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be aneffective treatment for extensive stage small cell lung cancer.

    PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brainworks when given with or without radiation therapy to other areas of the body in treatingpatients with extensive stage small cell lung cancer.

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  • CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma

    This phase II trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells workas a consolidative therapy following a donor non-myeloablative hematopoietic cell transplantin treating patients with leukemia or lymphoma. Giving total lymphoid irradiation andanti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growthof cells in the bone marrow, including normal blood-forming cells (stem cells) and cancercells. When the healthy stem cells from a donor are infused into the patient they may helpthe patient's bone marrow make stem cells, red blood cells, white blood cells, andplatelets. Sometimes the transplanted cells from a donor can make an immune response againstthe body's normal cells (called graft-versus-host disease). Giving cyclosporine andmycophenolate mofetil after the transplant may stop this from happening. Once the donatedstem cells begin working, the patient's immune system may see the remaining cancer cells asnot belonging in the patient's body and destroy them. Giving an infusion of the donor'swhite blood cells, such as CD8+ memory T-cells, may boost this effect and may be aneffective treatment to kill any cancer cells that may be left in the body (consolidativetherapy).

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  • Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors

    This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in thetreatment of patients younger than 22 years of age. Patients with recurrent or refractoryAT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RTwill receive alisertib as part of age- and risk-adapted chemotherapy. Radiation therapy willbe given to children ≥12 months of age. Patients with AT/RT and concurrent extra-CNS MRT areeligible.

    Alisertib will be administered as a single agent on days 1-7 of each 21-day cycle in allrecurrent patients enrolled on Stratum A. For the patients on the newly diagnosed strata (B,C or D), alisertib will be administered in sequence with chemotherapy and radiotherapy.

    This study has 3 primary strata: (A) children with recurrent/progressive AT/RT or extra-CNSMRT, (B) children < 36 months-old with newly diagnosed AT/RT, (C) children > 36 months oldwith newly diagnosed AT/RT. Children with concurrent MRT will be treated according to ageand risk stratification schemes outlined for strata B and C and will have additionaltreatment for local control. Children with synchronous AT/RT will be treated with age andCNS risk-appropriate therapy, and also receive surgery and/or radiation therapy for localcontrol of the non-CNS tumor.

    PRIMARY OBJECTIVES

    - To estimate the sustained objective response rate and disease stabilization inpediatric patients with recurrent or progressive AT/RT (atypical teratoid rhabdoidtumor in the CNS) (Stratum A1) treated with alisertib and to determine if the responseis sufficient to merit continued investigation of alisertib in this population.

    - To estimate the sustained objective response rate and disease stabilization inpediatric patients with recurrent or progressive extra-CNS MRT (malignant rhabdoidtumor outside the CNS) (Stratum A2) treated with alisertib and to determine if theresponse is sufficient to merit continued investigation of alisertib in thispopulation.

    - To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are youngerthan 36 months of age at diagnosis with no metastatic disease (Stratum B1) treated withalisertib in sequence with induction and consolidation chemotherapy and radiationtherapy (depending on age) and to determine if the rates are sufficient to meritcontinued investigation of alisertib in this population.

    - To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are youngerthan 36 months of age at diagnosis, with metastatic disease (Stratum B2) treated withalisertib in sequence with induction and consolidation chemotherapy and to determine ifthe rates are sufficient to merit continued investigation of alisertib in thispopulation.

    - To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are 3 yearsof age or greater at diagnosis with no metastatic disease and gross total resection ornear total resection (Stratum C1) treated with alisertib in sequence with radiationtherapy and consolidation chemotherapy and to determine if the rates are sufficient tomerit continued investigation of alisertib in this population.

    - To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are 3 yearsof age or greater at diagnosis with metastatic or residual disease (Stratum C2) treatedwith alisertib in sequence with radiation therapy and consolidation chemotherapy and todetermine if the rates are sufficient to merit continued investigation of alisertib inthis population.

    - To characterize the pharmacokinetics and pharmacodynamics of alisertib in pediatricpatients and to relate drug disposition to toxicity.

    SECONDARY OBJECTIVES

    - To estimate the duration of objective response and PFS in patients withrecurrent/progressive AT/RT and MRT (Strata A1 and A2).

    - To estimate PFS and OS distributions in patients with newly diagnosed AT/RT (Strata B1,B2, B3, C1 and C2).

    - To describe toxicities experienced by patients treated on this trial, specifically anytoxicities of alisertib when administered as a single agent or in combination withother therapy over multiple courses and toxicities related to proton or photonradiation therapy.

    - To describe the patterns of local and distant failure in newly diagnosed patients(Strata B1, B2, B3, C1 and C2). Local control relative to primary-site radiationtherapy, with criteria for infield, marginal, or distant failure will also be reporteddescriptively.

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  • Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

    This randomized phase III trial studies combination chemotherapy to see how well it workscompared to combination chemotherapy with topotecan hydrochloride in treating patients withnon-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristinesulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecanhydrochloride, work in different ways to stop the growth of tumor cells, either by killingthe cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more tumor cells. It is not yet known whether combinationchemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.

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  • Placebo-controlled Lymphedema Study for Arm or Leg Lymphedema

    This study compares the effectiveness of a study drug versus placebo in the treatment oflymphedema to the untreated condition, in the same individual..

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  • Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

    RATIONALE: Vorinostat may stop the growth of cancer cells by interfering with variousproteins needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin (GO),can block cancer growth in different ways. GO finds cancer cells and helps kill them bycarrying a cancer-killing substance to them. Giving vorinostat together with gemtuzumabozogamicin may kill more cancer cells.

    PURPOSE: This phase II trial is studying how well giving vorinostat together with gemtuzumabozogamicin works in treating older patients with previously untreated acute myeloidleukemia.

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  • Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

    This phase II trial is studying how well giving clofarabine and cytarabine together withfilgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML),advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugsused in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop thegrowth of cancer cells, either by killing the cells or by stopping them from dividing.Giving the drugs in different doses may kill more cancer cells. Colony stimulating factors,such as filgrastim, may increase the number of immune cells found in bone marrow orperipheral blood and may help the immune system recover from the side effects ofchemotherapy.

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  • Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

    The objective of this study is to assess the safety and tolerability, including the maximumtolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloidleukemia (AML). This study will also determine the pharmacokinetic (PK) parameters ofASP2215.

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  • Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia

    This clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patientswith untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used inchemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways tostop the growth of cancer cells, either by killing the cells, by stopping them fromdividing, or by stopping them from spreading.

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  • PI/II of Temozolomide & Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

    The purpose of this study is to investigate the safety and effectiveness of a combinationtreatment for glioblastoma multiforme utilizing radiotherapy with the FDA approvedchemotherapy drug temozolomide

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  • A Phase III Study of Atezolizumab Treatment Versus Observation as Adjuvant Therapy in Patients With PD-L1 Positive, High Risk Muscle Invasive Bladder Cancer After Cystectomy [IMvigor010]

    This study is to evaluate the efficacy and safety of adjuvant treatment with Atezolizumabcompared with observation in participants with PD-L1-selected muscle-invasive bladder cancer(MIBC) who are at high risk for recurrence following cystectomy.

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  • Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

    This randomized phase II trial studies how well giving vaccine therapy with or withoutbevacizumab works in treating patients with recurrent glioblastoma multiforme that can beremoved by surgery. Vaccines consisting of heat shock protein-peptide complexes made from aperson's own tumor tissue may help the body build an effective immune response to kill tumorcells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can blocktumor growth in different ways. Some block the ability of tumor cells to grow and spread.Others find tumor cells and help kill them. It is not yet known whether giving vaccinetherapy is more effective with or without bevacizumab in treating glioblastoma multiforme.

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  • Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia

    This phase II trial studies how well ruxolitinib phosphate works in treating patients withchronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinibphosphate may stop the growth of cancer cells by blocking some of the enzymes needed forcells to reproduce. This trial also studies the genetic makeup of patients. Certain genes incancer cells may determine how the cancer grows or spreads and how it may respond todifferent drugs. Studying how the genes associated with CNL and aCML respond to the studydrug may help doctors learn more about CNL and aCML and improve the treatment for thesediseases.

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  • Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

    This phase II trial studies how well giving bortezomib together with combinationchemotherapy works in treating patients with relapsed or refractory acute lymphoblasticleukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymesneeded for cell growth.

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  • S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

    RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes inpatients with invasive bladder cancer. It is not yet known whether extended pelviclymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.

    PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to seehow well it works compared to extended pelvic lymphadenectomy in treating patientsundergoing surgery for invasive bladder cancer.

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  • Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

    This research trial studies genetic testing in screening patients with stage IB-IIIAnon-small cell lung cancer that has been or will be removed by surgery. Studying the genesin a patient's tumor cells may help doctors select the best treatment for patients that havecertain genetic changes.

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  • A Comprehensive Study to Isolate Tumor-initiating Cells From Human Epithelial Malignancies

    We hypothesize that all human malignancies harbour a subpopulation of tumor initiatingcells/cancer stem cells (CSCs) that drives tumor development and potentially recurrence ormetastasis of the disease. The primary aim of this study is to develop strategies forprospective isolation/enrichment of CSCs from human tumors of different tissue origins. Inaddition, we will characterize the signaling pathways and/or tumor specific antigens thatare specific for CSCs, in order to specifically target these CSCs as the endpoint of thisstudy.

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  • Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

    This phase I trial studies the side effects and the best dose of lenalidomide when giventogether with combination chemotherapy in treating patients with relapsed or refractoryacute myeloid leukemia. Lenalidomide may stop the growth of acute myeloid leukemia byblocking blood flow to the cancer. Drugs used in chemotherapy, such as mitoxantronehydrochloride, etoposide, and cytarabine, work in different ways to stop the growth ofcancer cells, either by killing the cells or by stopping them from dividing. Givinglenalidomide and combination chemotherapy may be an effective treatment for acute myeloidleukemia.

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  • Phase II Temozolomide + Vorinostat in Patients (>60) w/ Newly Diagnosed or Relapse/Refractory AML

    The purpose of the study is to first determine if Temozolomide plus Vorinostat incombination can control relapsed or refractory AML and determine if this combination can besafely taken. The study will look at the side effects of the Temozolomide plus Vorinostat incombination and whether the treatment schedule is tolerated.

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  • Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer

    This phase I trial studies the side effects and best dose of recombinant interleukin-15 intreating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neckcancer that has spread to other places in the body and usually cannot be cured or controlledwith treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, madenaturally in the body and when made in the laboratory may help stimulate the immune systemin different ways and stop tumor cells from growing.

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  • 18F FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

    The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancerpatients. We will assess the uptake of this novel radiopharmaceutical in subjects withbreast cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiringantiangiogenesis treatment.

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  • Clinical and Pathologic Studies of Patients Undergoing Treatment With EGFR Inhibitors

    Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factorreceptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung,and head and neck. Blockade of the EGFR results in inhibition of multiple downstreampathways, leading to slowed tumor growth. In addition, these inhibitors may enhanceanti-tumor immune responses through uncharacterized mechanisms. While producing significantresponses in many settings, EGFR inhibitors also result in significant skin toxicity (rash)in a high percentage of patients. Multiple studies have correlated the presence and severityof rash with clinical response. Unfortunately, severe rash can often lead to dose delays,reductions, or even discontinuation of EGFR inhibitors, thus limiting their efficacy. Themechanism of both the rash and its correlation with tumor response is poorly understood.Skin biopsies display a robust leukocyte infiltrate, but a systematic analysis of the typeof infiltrating leukocytes, activation state, or homing receptor expression has not beenperformed. Chemokines and chemokine receptors control leukocyte trafficking to the skin andother tissue sites, and defined receptor profiles for skin-, gut-, and lung-homingleukocytes are well established. In this study, the investigators propose to evaluate thehoming phenotype of leukocytes from peripheral blood and skin biopsies of patients receivingEGFR inhibitors. The investigators will use RNA microarrays to evaluate the expression ofchemokines and other key genes regulated in skin during treatment. The investigators willutilize in vitro methods to investigate effects of EGFR inhibitors on imprinting of T celltissue-specific homing receptors. The investigators will examine correlations among thepathologic data, clinical findings, and tumor response. If validated, peripheral bloodevaluation could potentially be used as a predictive indicator for patients receiving EGFRinhibitors. This study may also identify novel targets for limiting skin toxicity whilereceiving EGFR inhibitors, thus allowing maximal dosing and clinical response from theseagents.

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  • Oral Rigosertib for Squamous Cell Carcinoma

    The primary objective of this study is to determine if tumors in patients withpapillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longerresponds to standard therapy will decrease in size following treatment with theinvestigational drug, rigosertib sodium (ON 01910.Na). A secondary objective is to determineif treatment with rigosertib causes any side effects.

    Rigosertib is an investigational drug, which means that it has not been approved by the U.S.Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as anew anticancer drug. Tests that we have done in the laboratory suggest that rigosertib worksby blocking cell division in cancer cells and causing them to die.

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  • AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

    This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to beconducted in the United States and Spain.

    Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG479 that is safe and tolerable.

    Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected inPart 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC(non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, andsarcoma.

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  • Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy

    RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receivingcisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective thanno additional treatment in preventing hearing loss.

    PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well itworks in preventing hearing loss in young patients receiving cisplatin for newly diagnosedgerm cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or othermalignancy.

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  • A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors

    A Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, andpharmacokinetics of coadministration of MPDL3280A and of cobimetinib in patients withmetastatic or locally advanced cancer for which no standard of care exists.

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  • Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

    This randomized phase III trial studies how well blinatumomab works compared with standardcombination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia thathas returned after a period of improvement (relapsed). Monoclonal antibodies, such asblinatumomab, may interfere with the ability of tumor cells to grow and spread. It is notyet known whether standard combination chemotherapy is more effective than blinatumomab intreating relapsed B-cell acute lymphoblastic leukemia.

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  • Collecting and Storing Biological Samples From Patients With Ewing Sarcoma

    This research study is collecting and storing samples of tumor tissue, bone marrow, andblood from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bonemarrow, and blood from patients with cancer to test in the laboratory may help the study ofcancer in the future.

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  • National Breast Cancer and Lymphedema Registry

    The purpose of the National Breast Cancer Lymphedema Registry is to collect healthinformation in order to study the lymphedema as a complication of breast cancer treatment.The investigators hope to learn whether early diagnosis will help to prevent lymphedema or,if it does occur, to reduce the severity.

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  • Enrollment on the Childhood Cancer Research Network (CCRN) of the Children s Oncology Group

    Background:

    - The Children s Oncology Group has established a research network, the Childhood CancerResearch Network (CCRN), to collect information about children with cancer and otherconditions that are benign but involve abnormal cell growth in order to help doctors andscientists better understand childhood cancer. The CCRN's goal is to collect clinicalinformation about every child diagnosed with cancer and similar conditions in the UnitedStates and Canada, to allow researchers to study patterns, characteristics, and causes ofchildhood cancer. The information can also help researchers study the causes of childhoodcancer. To expand the CCRN, parents of children who have been diagnosed with cancer will beasked to provide information about themselves and their child for research purposes.

    Objectives:

    - To obtain informed consent from parents (and the child, when appropriate) of infants,children, adolescents, and young adults newly diagnosed with cancer to enter theirnames and certain information concerning their child into the Childhood Cancer ResearchNetwork.

    - To obtain informed consent from parents (and the child, when appropriate) of infants,children, adolescents, and young adults newly diagnosed with cancer for permission tobe contacted in the future to consider participating in non-therapeutic and preventionresearch studies involving the parents and/or the child.

    Eligibility:

    - Parents of children who have been seen at or treated by a hospital that is a member of theChildren s Oncology Group.

    Design:

    - Parents will provide permission to have personal information sent from their child shospital to the CCRN, including the child and parents' names; child's gender, birthdate, race, and ethnicity; information about the disease; and the treating institution.

    - Parents will also give permission for CCRN to contact the diagnostic laboratory toobtain specific information about the tumor or cancer cells.

    - Parents will be asked if they are willing to be contacted in the future to considerparticipating in CCRN research studies, and will provide contact information (name,home address, and telephone number) to be entered in the CCRN.

    - Parents or patients who change their minds about having information available in theCCRN can ask the treatment institution to restrict access to the identifyinginformation. Parents or patients who refuse to have information included in the CCRN orbe contacted in the future will still be able to enter clinical cancer researchstudies.

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  • Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer

    This randomized phase II trial studies how well positron emission tomography (PET)/computedtomography (CT)-guided radiation therapy works compared to standard radiation therapy intreating patients with stage III non-small cell lung cancer. Radiation therapy useshigh-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans,to guide the radiation therapy, may help doctors deliver higher doses directly to the tumorand cause less damage to healthy tissue.

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  • Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

    The primary purpose of the Research Database is to have a comprehensive source ofobservational data that can be used to study HSC transplantation.

    A secondary purpose of the Research Database is to have a comprehensive source of data tostudy marrow toxic injuries.

    Objectives:

    To learn more about what makes stem cell transplants work well, such as determining thefollowing:

    - how well recipients recover from their transplant

    - how recovery after a transplant can be improved

    - how access to transplant for different groups of patients can be improved

    - how well donors recover from the collection procedures

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  • Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

    RATIONALE: Collecting and storing samples of tumor tissue and blood from patients to test inthe laboratory may help the study of cancer in the future.

    PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissuefrom patients with osteosarcoma.

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  • Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

    RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancerto study in the laboratory may help doctors learn more about cancer and help predict therecurrence of cancer.

    PURPOSE: This research study is collecting and storing samples of bone marrow and blood frompatients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma.

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  • Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

    The purpose of this study is to determine the long-term safety of a fixed-dose, dailyregimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocyticleukemia/small lymphocytic leukemia (CLL/SLL).

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  • Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

    This partially randomized phase III trial studies different combinations of risk-adaptedchemotherapy regimens and their side effects and comparing how well they work in treatingyounger patients with newly diagnosed standard-risk acute lymphoblastic leukemia orB-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began(localized). Drugs used in chemotherapy work in different ways to stop the growth of cancercells, either by killing the cells, by stopping them from dividing, or by stopping them fromspreading. Giving more than one drug (combination chemotherapy), giving the drugs indifferent doses, and giving the drugs in different combinations may kill more cancer cells.

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  • Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    This research trial studies a risk-based classification system for patients with newlydiagnosed acute lymphoblastic leukemia. Gathering health information about patients withacute lymphoblastic leukemia may help doctors learn more about the disease and plan the besttreatment.

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  • Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

    The purpose of this study is to assess the feasibility and efficacy of a novel form oftherapy—haploidentical NK cell transplantation—in patients with standard-risk AML. Inaddition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newlydiagnosed patients with AML and attempt to optimize outcome through the use of MRD-adaptedtherapy and further improvements in supportive care.

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  • Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

    This randomized phase III trial is studying how well combination chemotherapy works intreating young patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugsused in chemotherapy work in different ways to stop the growth of cancer cells, either bykilling the cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) and giving the drugs in different doses and in different combinations may killmore cancer cells.

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  • Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

    This clinical trial studies cancer survivors to identify those who are at increased risk ofdeveloping late-occurring complications after undergoing treatment for childhood cancer. Apatient's genes may affect the risk of developing complications, such as congestive heartfailure, heart attack, stroke, and second cancer, years after undergoing cancer treatment.Genetic studies may help doctors identify survivors of childhood cancer who are more likelyto develop late complications.

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  • Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma

    RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treatbrain tumors in young children. Using chemotherapy gives the brain more time to developbefore radiation is given. The chemotherapy in this study includes the drug methotrexate.This drug was an important part of the two clinical trials which resulted in the bestsurvival results for children less than 3 years of age with medulloblastoma. Most patientstreated on this trial will also receive radiation which is carefully targeted to the area ofthe tumor. This type of radiation (focal conformal or proton beam radiotherapy) may resultin fewer problems with thinking and learning than radiation to the whole brain and spinalcord.

    PURPOSE: This clinical trial is studying how well giving combination chemotherapy togetherwith radiation therapy works in treating young patients with newly diagnosed central nervoussystem tumors.

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  • Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma

    This phase II trial studies how well cixutumumab and temsirolimus work in treating patientswith recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can blocktumor growth in different ways. Some block the ability of tumor cells to grow and spread.Others find tumor cells and help kill them or carry tumor-killing substances to them.Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed forcell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.

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  • Genomic Analysis of Pediatric Bone Tumors

    To determine whether gene expression analysis of primary tumor samples before and afterchemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas(Ewings sarcoma (ES) and Osteosarcoma(OS)).

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  • Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia

    This pilot clinical trial studies brentuximab vedotin in treating patients with advancedsystemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximabvedotin, can block cancer growth in different ways. Some block the ability of cancer cellsto grow and spread. Others find cancer cells and help kill them or carry cancer-killingsubstances to them

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  • Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

    This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib withchemoradiation therapy works in treating patients with stage III non-small cell lung cancer.Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapythat delivers a high dose of radiation directly to the tumor may kill more tumor cells andcause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin,etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumorcells, either by killing the cells, by stopping them from dividing, or by stopping them fromspreading. It is not yet known whether giving erlotinib hydrochloride is more effective thancrizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.

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  • Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

    Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth oftumor cells, either by killing the cells or by stopping them from dividing. It is not yetknown which radiation therapy regimen is more effective when given together withchemotherapy in treating patients with limited-stage small cell lung cancer. This randomizedphase III trial is comparing different chest radiation therapy regimens to see how well theywork in treating patients with limited-stage small cell lung cancer.

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  • A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects With Melanoma Metastatic to the Brain Treated With Nivolumab in Combination With Ipilimumab Followed by Nivolumab Monotherapy (CheckMate 204)

    This is an open-label, multi-site Phase 2 study of Nivolumab combined with Ipilimumabfollowed by Nivolumab monotherapy for the treatment of subjects with Melanoma metastatic tothe brain. Patients with histologically confirmed Malignant melanoma and asymptomatic brainmetastases are eligible for the study.

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  • 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

    To develop and investigate a novel radiotherapy technique for preserving lung function basedon a map of lung function.

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  • Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma

    This randomized phase III trial is studying maintenance chemotherapy to see how well itworks compared to observation following induction chemotherapy and radiation therapy intreating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such asvincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work indifferent ways to stop the growth of tumor cells, either by killing the cells or by stoppingthem from dividing. Giving more than one drug (combination chemotherapy) may kill more tumorcells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiationtherapy that delivers a high dose of radiation directly to the tumor may kill more tumorcells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy maykill more tumor cells and allow doctors to save the part of the body where the cancerstarted.

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  • Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

    The purpose of this study is to test the safety of selinexor (KPT-330) and to find thehighest dose of selinexor (KPT-330) that can be given safely when it is combined with twochemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: PhaseI and Phase II.

    The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we cangive to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine.

    The goal of the Phase II portion of the study is to give the highest dose of selinexor(KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safefor children with leukemia or MDS. The investigators will examine the effect of thiscombination treatment.

    PRIMARY OBJECTIVE:

    - Determine a tolerable combination of selinexor, fludarabine, and cytarabine inpediatric patients with relapsed or refractory hematologic malignancies included acutemyeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acuteleukemia (MPAL) and myelodysplastic syndrome (MDS).

    SECONDARY OBJECTIVES:

    - To characterize the pharmacokinetics of selinexor, when administered in tablet form,after the first dose and at steady-state, as well as in combination with fludarabineand cytarabine

    - To estimate the overall response rate of selinexor given with fludarabine andcytarabine in patients with relapsed or refractory hematologic malignancies

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  • Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

    This pilot clinical trial study will assess the inflammatory response of brain tumors orother central nervous system conditions in pediatric and adult patients usingferumoxytol-enhanced MRI. Imaging features will be correlated with the number ofinflammatory cells (macrophages) at histopathology. Determining the extent of inflammationassociated with pathologies in the central nervous system may be helpful for diagnostic andprognostic purposes as well as monitoring treatment response of current and futureimmunotherapies.

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  • Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

    To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective indelaying/preventing pulmonary relapse in osteosarcoma patients in complete surgicalremission following one or two prior pulmonary relapses.

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  • FLT-PET Imaging of Brain Tumors in Children

    Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging isimportant in the management of these tumors, but current imaging methods have limitations inproviding the necessary information for optimal treatment of these patients. The goal ofthis study is to evaluate the potential utility of positron emission tomography (PET) with3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors inchildren. Funding source - FDA Office of Orphan Product Development (OOPD)

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  • Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    This randomized phase III trial studies ibrutinib and rituximab to see how well they workcompared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients withuntreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop thegrowth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used inchemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways tostop the growth of cancer cells, either by killing the cells, by stopping them fromdividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, canblock cancer growth in different ways. Some block the ability of cancer to grow and spread.Others find cancer cells and help kill them or carry cancer-killing substances to them. Itis not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab are moreeffective than ibrutinib and rituximab in treating patients with untreated chroniclymphocytic leukemia or small lymphocytic lymphoma.

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  • Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases

    The investigators will learn from this study if the CyberKnife radiosurgery (CK RS)treatment of patients with 1-3 versus 4 or more brain metastases results in the same overallsurvivals. The importance of this new knowledge will be to determine the treatment efficacyof CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would givedata to support either the continuation or modification of the CK RS treatment of patientswith brain metastases.

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  • Stanford Accelerated Recovery Trial (START)

    The goal of this study is to determine whether administering Gabapentin prior to surgeryaffects duration of pain and opioid use post-surgery. The investigators aim to comparegabapentin to placebo in a prospective, randomized clinical trial in which patients will befollowed post-surgery until pain resolves and opioid use ceases.

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  • MEK Inhibitor MEK162, Idarubicin, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

    This phase I trial studies the MEK inhibitor MEK162 to see if it is safe in patients whencombined with idarubicin and cytarabine. MEK inhibitor MEK162 may stop the growth of cancercells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,such as idarubicin and cytarabine, work in different ways to stop the growth of cancercells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitorMEK162, cytarabine, and idarubicin may be an effective treatment for acute myeloid leukemia.

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  • Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma

    This study will investigate gene expression profiles in normal human lung tissue, lungcarcinoma and metastatic tumor to the lung. The expression of up to 20,000 genes in a givenlung tissue sample will be examined by cDNA microarray analysis and compared to normal lungtissue. In addition, we hope to identify a particular subset of lung cancer cells with anenhanced capacity for proliferation and self-renewal , analogous to the stem cells recentlyidentified for certain types of leukemia, breast cancer and brain tumors.

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  • A Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor210]

    This phase II, single-arm study was designed to evaluate the effect of Atezolizumabtreatment in patients with locally advanced or metastatic urothelial bladder cancer.Patients will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of patients who aretreatment-naïve and ineligible for platinum-containing therapy. Cohort 2 will containpatients who have progressed during or following a prior platinum-based chemotherapyregimen. Patients in both cohorts will be given a 1200 mg intravenous (IV) dose ofAtezolizumab on Day 1 of 21-day cycles. Treatment of patients in Cohort 1 will continueuntil disease progression per RECIST v1.1 criteria or unmanageable toxicity. Treatment ofpatients in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.Patients will be followed for up for 2 years.

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  • A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

    Historically, medulloblastoma treatment has been determined by the amount of leftoverdisease present after surgery, also known as clinical risk (standard vs. high risk). Recentstudies have shown that medulloblastoma is made up of distinct molecular subgroups whichrespond differently to treatment. This suggests that clinical risk alone is not adequate toidentify actual risk of recurrence. In order to address this, we will stratifymedulloblastoma treatment in this phase II clinical trial based on both clinical risk (low,standard, intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH).This stratified clinical and molecular treatment approach will be used to evaluate thefollowing:

    - To find out if participants with low-risk WNT tumors can be treated with a lower doseof radiation to the brain and spine, and a lower dose of the chemotherapy drugcyclophosphamide while still achieving the same survival rate as past St. Jude studieswith fewer side effects.

    - To find out if adding targeted chemotherapy after standard chemotherapy will benefitparticipants with SHH positive tumors.

    - To find out if adding new chemotherapy agents to the standard chemotherapy will improvethe outcome for intermediate and high risk Non-WNT Non-SHH tumors.

    - To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduceddose cyclophosphamide and compare this to participants from the past St. Jude study.

    All participants on this study will have surgery to remove as much of the primary tumor assafely possible, radiation therapy, and chemotherapy. The amount of radiation therapy andtype of chemotherapy received will be determined by the participant's treatment stratum.Treatment stratum assignment will be based on the tumor's molecular subgroup assignment andclinical risk.

    The participant will be assigned to one of three medulloblastoma subgroups determined byanalysis of the tumor tissue for tumor biomarkers:

    - WNT (Strata W): positive for WNT biomarkers

    - SHH (Strata S): positive for SHH biomarkers

    - Non-WNT Non-SHH, Failed, or Indeterminate (Strata N): negative for WNT and SHHbiomarkers or results are indeterminable

    Participants will then be assigned to a clinical risk group (low, standard, intermediate, orhigh) based on assessment of:

    - How much tumor is left after surgery

    - If the cancer has spread to other sites outside the brain [i.e., to the spinal cord orwithin the fluid surrounding the spinal cord, called cerebrospinal fluid (CSF)]

    - The appearance of the tumor cells under the microscope

    - Whether or not there are chromosomal abnormalities in the tumor, and if present, whattype (also called cytogenetics analysis).

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  • Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant

    This phase II trial studies how well giving fluticasone propionate, azithromycin, andmontelukast sodium (FAM) together works in treating patients with bronchiolitis obliteranswho previously underwent stem cell transplant. FAM may be an effective treatment forbronchiolitis obliterans

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  • Feasibility Neurocognitive Outcome After Transplant

    This pilot study will primarily be evaluated by feasibility and adherence to an iPad-basedneurocognitive intervention program. It will secondarily be evaluated by performance on theneurocognitive testing post-transplant and change in performance in subsequent years.

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  • A Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer - "BIRCH"

    This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab inpatients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer.Patients will receive Atezolizumab 1200 mg intravenously every 3 weeks as long as patientsare experiencing clinical benefit as assessed by the investigator, i.e., in the absence ofunacceptable toxicity or symptomatic deterioation attributed to disease progression.

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  • An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

    The purpose of this study is to show that Nivolumab will improve progression free survivalin subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer whencompared to chemotherapy

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  • Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer or Metastatic Large Cell Neuroendocrine Non-small Cell Lung Cancer

    This randomized phase I/II trial studies the side effects and best dose of veliparib whengiven together with or without cisplatin and etoposide and to see how well they work intreating patients with extensive stage small cell lung cancer or large cell neuroendocrinenon-small cell lung cancer that has spread to other parts of the body. Drugs used inchemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth oftumor cells, either by killing the cells, by stopping them from dividing, or by stoppingthem from spreading. Veliparib may stop the growth of tumor cells by blocking some of theenzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib maywork better in treating patients with extensive stage small cell lung cancer or metastaticlarge cell neuroendocrine non-small cell lung cancer.

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  • Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC

    Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 topatients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except incountries where ALK inhibitors are not approved or available. The protocol will furtherevaluate the safety of LDK378 in patients with ALK(+) NSCLC.

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  • Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

    This is the first human study to use X-396, a drug being developed for treatment of advancedcancers. The initial purpose of the study is to determine the largest amount of X-396 thatcan be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2dose has been determined, an expansion phase will assess the preliminary anti-tumor activityof X-396 in ALK-positive non-small cell lung cancer. The study will also provide earlyinformation on how the body handles the drug (pharmacokinetics) and on the efficacy ofX-396.

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  • Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)

    There will be two parts to this study. The dose escalation phase will evaluate the safety,preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as wellas define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with erlotinib inadults with epidermal growth factor receptor (EGFR)-mutated, EGFR tyrosine kinase inhibitor(TKI) naive metastatic non-small cell lung cancer (NSCLC). During this phase, participantswill be sequentially enrolled to receive progressively increasing doses of MMB incombination with erlotinib. Escalation of MMB doses will proceed to the MTD, defined as thehighest tested dose associated with dose-limiting toxicities (DLT) during the first 28 daysof combined erlotinib and MMB treatment. There will be four dose levels and each treatmentcycle will consist of 28 days.

    The dose expansion phase will evaluate the efficacy, safety, and tolerability of erlotinibcombined with MMB administered at the MTD versus erlotinib alone in adults with EGFR-MutatedEGFR TKI naive metastatic NSCLC.

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  • Study of Two Doses of MK-3475 (Pembrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

    This study will compare two doses of pembrolizumab versus docetaxel in participants withnon-small cell lung cancer (NSCLC) who have experienced disease progression afterplatinum-containing systemic therapy. Participants will be assigned randomly to receiveeither Low Dose or High Dose pembrolizumab every three weeks (Q3W), or docetaxel at 75mg/m^2 Q3W. This study will use an adaptive trial design so that the total number ofparticipants randomized will depend upon demonstration of sufficient objective responses atinterim analysis. If the pembrolizumab Low Dose arm is closed, participants may receivepembrolizumab High Dose therapy.

    Based on the positive outcome of the Overall Survival (OS) analysis, Protocol Amendment 12enables eligible participants who were allocated to docetaxel and experienced diseaseprogression, to be permitted to crossover to receive MK-3475 Low Dose Q3W as long asInclusion/Exclusion criteria are met. These participants will be participating in theCross-Over Phase.

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  • Phase II Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer

    This phase II trial studies how well pegylated irinotecan NKTR 102 works in treatingpatients with non-small cell lung cancer, small cell lung cancer, or breast cancer that hasspread to the brain and does not respond to treatment. Pegylated irinotecan NKTR 102 maystop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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  • S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer

    The primary focus of this study is to see if looking at tumor biomarkers using a programcalled coexpression extrapolation or "COXEN" may predict a patient's response tochemotherapy before surgery.

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  • Phase 1/2 Study of AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

    Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD,and clinical activity evaluation of orally administered AG-221 in subjects with advancedhematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalationphase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose(RP2D) and an expansion phase to further evaluate the safety, tolerability and clinicalactivity of AG-221 in select populations.

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  • Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients

    Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI)that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) whilesparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic(PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD)and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety andefficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFRmutation.

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  • Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors

    Primary Objectives:

    Phase 1 Part:

    To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) ofcabazitaxel as a single agent in pediatric patients with recurrent or refractory solidtumors including tumors of the central nervous system.

    Phase 2 Part:

    To determine the objective response rate (complete and partial response) and the duration ofresponse to cabazitaxel as a single agent in patients with recurrent or refractory highgrade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).

    Secondary Objectives:

    Phase 1 Part:

    To characterize the safety and tolerability of cabazitaxel in patients with recurrent orrefractory solid tumors including tumors of the central nervous system.

    To characterize the pharmacokinetic (PK) profile of cabazitaxel in patients with recurrentor refractory solid tumors including tumors of the central nervous system.

    To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel inpatients with recurrent or refractory solid tumors including tumors of the central nervoussystem.

    Phase 2 Part:

    To characterize the safety and tolerability of cabazitaxel in patients with recurrent orrefractory HGG or DIPG.

    To estimate progression free survival in patients with recurrent or refractory HGG or DIPG.

    To estimate overall survival in patients with recurrent or refractory HGG or DIPG.

    To characterize the plasma PK profile of cabazitaxel in patients with recurrent orrefractory HGG or DIPG.

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  • PET/CT and Whole-Body MRI for Detection of Skeletal and Soft Tissue Metastases

    Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging toolfor cancer detection and monitoring response to therapy. However, not all cancers areidentified reliably due to variable rates of glucose metabolism. Whole-body MRI emergescurrently as an excellent modality for morphological characterization of soft tissue andskeletal lesions. Sodium Fluorine-18 (F-18) was used in the 1970's for bone scanning and canbe used as a skeletal tracer in current PET/CT scanners. The direct comparison of F-18/F-18FDG PET/CT and whole-body MRI for skeletal metastases detection was not attempted to date.However, such an approach has the potential to improve cancer diagnosis, staging, prognosis,and therapy monitoring. The combination of these technologies may also allow for improvedscreening or earlier cancer detection. We will attempt a pilot study with 10 patients toacquire the preliminary results needed to proceed with additional 90 subjects.

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  • Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients

    The primary aim of this study is to determine whether we can identify human lung cancertumor cells in the peripheral blood of lung cancer patients.

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  • Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers

    The purpose of this study is to identify and confirm new blood and tissue markers forprognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, hasbeen shown to increase the risk of tumor spread and enhance tumor resistance to the standardtreatment of radiation and chemotherapy in head and neck and lung cancers. We have recentlyidentified several proteins or markers in the blood and in tumors (including osteopontin,lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory thatmay be able to identify tumors with low oxygen levels or more aggressive behaving tumors.

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  • Neuropsychological and Behavioral Testing in Younger Patients With Cancer

    This research trial studies neuropsychological (learning, remembering or thinking) andbehavioral testing in younger patients with cancer. Collecting information over time from aseries of tests may help doctors develop effective tests to measure neuropsychological andbehavioral function of patients with cancer.

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  • Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer

    This study is collecting and storing malignant, borderline malignant neoplasms, and relatedbiological samples from young patients with cancer. Collecting and storing samples of tumortissue, blood, and bone marrow from patients with cancer to study in the laboratory may helpthe study of cancer in the future.

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  • DNA Analysis of Tumor Tissue Samples From Patients With Diffuse Brain Stem Glioma

    This multi-institutional study will prospectively collect tumor and constitutional tissuesamples from patients with diffuse brainstem glioma and other types of brainstem gliomaseither during therapy or at autopsy to perform an extensive analysis of genetic andmolecular abnormalities in these tumors.

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  • Study of Blood Samples From Newborns With Down Syndrome

    RATIONALE: Studying the genes expressed in samples of blood from patients with Down syndromemay help doctors identify biomarkers related to cancer.

    PURPOSE: This research study is looking at blood samples from newborns with Down syndrome.

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  • Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer (Cetuximab Closed as of 05/14/10)

    RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in differentways to stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonalantibodies, such as panitumumab, can block tumor growth in different ways. Some block theability of tumor cells to grow and spread. Others find tumor cells and help kill them orcarry tumor-killing substances to them. Giving these treatments before surgery may make thetumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yetknown whether chemotherapy and radiation therapy are more effective when given with orwithout panitumumab in treating patients with non-small cell lung cancer. (cetuximab closedas of 05/14/10)

    PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy tosee how well they work when given with or without panitumumab in treating patients withstage IIIA non-small cell lung cancer. (cetuximab closed as of 05/14/10)

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  • Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

    This phase I/II trial studies the side effects and the best dose of selumetinib and how wellit works in treating or re-treating young patients with low grade glioma that has come back(recurrent) or does not respond to treatment (refractory). Selumetinib may stop the growthof tumor cells by blocking some of the enzymes needed for cell growth.

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  • Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer

    We will combine an oral investigational VEGF inhibitor called papopanib which is beingstudied in kidney cancer will be combined with standard chemotherapy called taxol inpatients with relapsed recurrent urothelial cancer.

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  • Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma

    This phase I trial is studying the side effects and the best dose of vorinostat when giventogether with isotretinoin to see how well it works in treating patients with high-riskrefractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells byblocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat workbetter by making tumor cells more sensitive to the drug. Giving vorinostat together withisotretinoin may be an effective treatment for neuroblastoma.

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  • Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

    This randomized phase II trial studies how well giving temozolomide and irinotecanhydrochloride together with or without bevacizumab works in treating young patients withrecurrent or refractory medulloblastoma or central nervous system (CNS) primitiveneuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecanhydrochloride, work in different ways to stop the growth of tumor cells, either by killingthe cells, by stopping them from dividing, or by stopping them from spreading. Monoclonalantibodies, such as bevacizumab, can block tumor growth in different ways. Some block theability of tumor cells to grow and spread. Others find tumor cells and help kill them orcarry tumor-killing substances to them. It is not yet known whether temozolomide andirinotecan hydrochloride are more effective with or without bevacizumab in treatingmedulloblastoma or CNS primitive neuroectodermal tumors.

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  • Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

    A research study on distinguishing between cancer and infection or inflammation using MRIand a new contrast agent (ferumoxytol). We hope to learn how to tell the difference betweenthese two conditions with a simple MRI scan.

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  • Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    This randomized phase III trial studies how well bortezomib and sorafenib tosylate work intreating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenibtosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cellgrowth. Drugs used in chemotherapy work in different ways to stop the growth of cancercells, either by killing the cells or by stopping them from dividing. Giving bortezomib andsorafenib tosylate together with combination chemotherapy may be an effective treatment foracute myeloid leukemia.

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  • Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor

    RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancertreatment.

    PURPOSE: This phase II randomized trial studies how well modafinil works in treatingchildren with memory and attention problems caused by cancer treatment for a brain tumor.

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  • Molecular Analysis of Thoracic Malignancies

    A research study to learn about the biologic features of cancer development, growth, andspread. We are studying components of blood, tumor tissue, normal tissue, and other fluids,such as urine, cerebrospinal fluid, abdominal or chest fluid in patients with cancer. Ouranalyses of blood, tissue, and/or fluids may lead to improved diagnosis and treatment ofcancer by the identification of markers that predict clinical outcome, markers that predictresponse to specific therapies, and the identification of targets for new therapies.

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  • Phase II Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

    A research study using a method of treating lung cancer with focused radiation calledStereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate theeffectiveness of individualizing the dose of radiation used to treat lung tumors with SABRbased on tumor-specific factors.

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  • Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas

    This phase I/II trial studies the side effects and the best dose of veliparib when giventogether with radiation therapy and temozolomide and to see how well they work in treatingyounger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growthof tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapyuses high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such astemozolomide, work in different ways to stop the growth of tumor cells either by killing thecells or by stopping them from dividing. Giving veliparib with radiation therapy andtemozolomide may kill more tumor cells.

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  • Combination Chemotherapy With or Without Rituximab in Treating Younger Patients With Stage III-IV Non-Hodgkin Lymphoma or B-Cell Acute Leukemia

    This randomized phase II/III trial studies how well combination chemotherapy with or withoutrituximab works in treating younger patients with stage III-IV non-Hodgkin lymphoma orB-cell acute leukemia. Drugs used in chemotherapy work in different ways to stop the growthof cancer cells, either by killing the cells, by stopping them from dividing, or by stoppingthem from spreading. Monoclonal antibody, such as rituximab, may block cancer growth indifferent ways by targeting certain cells. It is not yet known whether combinationchemotherapy together with rituximab is more effective in treating patients with non-Hodgkinlymphoma or B-cell acute leukemia.

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  • Double Cord Versus Haploidentical (BMT CTN 1101)

    Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia orlymphoma. Family members,unrelated donors or banked umbilical cordblood units with similartissue type can be used for HCT. This study will compare the effectiveness of two new typesof bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrowdonated from family members with only partially matched bone marrow; and, one that uses twopartially matched cord blood units.

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  • Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

    Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in differentways to stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapywith radiation therapy may kill more tumor cells. This phase II trial studies how wellchemotherapy and radiation therapy work in treating younger patients with newly diagnosedcentral nervous system germ cell tumors.

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  • Phase I/II MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

    For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT witha T cell depleted graft, the infusion of naturally occurring regulatory T cells withconventional T cells (T cell addback) in pre-defined doses and ratios will reduce theincidence of acute graft vs host disease while augmenting the graft vs leukemia effect andimproving immune reconstitution.

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  • Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma

    This phase I trial studies the side effects and best dose of lenalidomide when giventogether with dinutuximab with or without isotretinoin in treating younger patients withneuroblastoma that does not respond to treatment or that has come back. Drugs used inchemotherapy, such as lenalidomide and isotretinoin, work in different wants to stop thegrowth of tumor cells, either by killing the cells, by stopping them from dividing, or bystopping them from spreading. Monoclonal antibodies, such as dinutuximab, may interfere withthe ability of tumor cells to grow and spread. Giving more than one drug (combinationchemotherapy) together with dinutuximab therapy may kill more tumor cells.

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  • Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

    This research study is a Phase II clinical trial, which tests the safety and effectivenessof an investigational drug to learn whether the drug works in treating a specific cancer."Investigational" means that the drug is still being studied. It also means that the FDA hasnot yet approved afatinib for use in patients.

    In this research study the investigators are looking to see if taking afatinib after surgeryworks better when taken over a short period of time, compared to a long period of time.

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  • A Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer - "FIR"

    This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab inpatients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer(NSCLC). Patients will receive an intravenous dose of 1200 mg Atezolizumab on Day 1 of21-day cycles until disease progression.

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  • Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    This phase I trial studies the side effects and best dose of lenalidomide when giventogether with ibrutinib in treating patients with chronic lymphocytic leukemia or smalllymphocytic lymphoma that has returned after a period of improvement or does not respond totreatment. Biological therapies, such as lenalidomide, may stimulate the immune system indifferent ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancercells by blocking some of the enzymes needed for cell growth. Giving lenalidomide togetherwith ibrutinib may work better in treating chronic lymphocytic leukemia or small lymphocyticlymphoma.

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  • Study of MLN4924 Plus Azacitidine in Treatment-Naïve Patients With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older

    This study is an open-label, multicenter, phase 1b, dose-escalation study of MLN4924 incombination with azacitidine in adult patients with AML. The patient population will consistof patients 60 years of age or older, previously diagnosed with World HealthOrganization(WHO)-defined AML, who are unlikely to benefit from standard induction therapyand who have not received definitive treatment for AML or prior treatment with azacitidineor decitabine.

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  • Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancercells, either by killing the cells or by stopping them from dividing. Giving more than onedrug (combination chemotherapy) may kill more cancer cells.

    PURPOSE: This phase II trial is studying how well combination chemotherapy works in treatingyoung patients with newly diagnosed acute lymphoblastic leukemia.

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  • Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

    This phase III trial is studying combination chemotherapy to see how well it works intreating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used inchemotherapy work in different ways to stop the growth of cancer cells, either by killingthe cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more cancer cells.

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  • A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-like Sarcomas

    Although regorafenib was approved for use in patients who had progressive GIST despiteimatinib and/or sunitinib on the basis of phase II and phase III data, it has not beenexamined in a systematic fashion in patients with other forms of sarcoma.

    Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, andevidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-likesarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) suchas regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (smallmolecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinibhave overlapping panels of kinases that are inhibited simultaneously. While not equivalent,most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelialgrowth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking toa common mechanism of action of several of these agents.

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  • Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors

    This phase I trial studies the side effects and best dose of palbociclib isethionate intreating younger patients with central nervous system tumors that have grown, come back, ornot responded to treatment. Palbociclib isethionate may stop the growth of tumor cells byblocking some of the enzymes needed for cell growth.

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  • Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase III trial studies combination chemotherapy with or without lestaurtinib with tosee how well they work in treating younger patients with newly diagnosed acute lymphoblasticleukemia. Drugs used in chemotherapy work in different ways to stop the growth of stopcancer cells, either by killing the cells, by stopping them from dividing, or by stoppingthem from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some ofthe enzymes needed for cell growth. It is not yet known whether combination chemotherapy ismore effective with or without lestaurtinib in treating acute lymphoblastic leukemia.

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  • A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

    This is a Phase 2, open label, multicenter, study evaluating the efficacy and safety ofABT-199 in relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion.One hundred seven (107) subjects were enrolled in the main cohort, with evaluation ofefficacy as the primary objective, and approximately 50 subjects will be enrolled in thesafety expansion cohort to evaluate safety and updated tumor lysis syndrome prophylaxis andmanagement measures. Enrollment into the main cohort is closed. Enrollment into the safetyexpansion cohort is ongoing.

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  • Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

    RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in differentways to stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in differentways. Some block the ability of tumor cells to grow and spread. Others find tumor cells andhelp kill them or carry tumor-killing substances to them. Bevacizumab may also stop thegrowth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexeddisodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth.It is not yet known whether giving bevacizumab or pemetrexed disodium alone or incombination is more effective in treating non-squamous non-small cell lung cancer.

    PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodiumalone or in combination after induction therapy to see how well they work in treatingpatients with advanced non-squamous non-small cell lung cancer.

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  • A Study of Pemetrexed in Children With Recurrent Cancer

    To determine the response rate of pemetrexed given every 21 days for the treatment ofchildren with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitiveneuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma,medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.

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  • Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

    This phase II trial is studying the side effects and how well cixutumumab works in treatingpatients with relapsed or refractory solid tumors. Monoclonal antibodies, such ascixutumumab, can block tumor growth in different ways. Some block the ability of tumor cellsto grow and spread. Others find tumor cells and help kill them or carry tumor-killingsubstances to them.

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  • Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma

    Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2in treating young patients who have refractory or recurrent neuroblastoma. Biologicaltherapies use different ways to stimulate the immune system and stop cancer cells fromgrowing. Combining interleukin-2 with interleukin-12 may kill more tumor cells.

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  • Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

    This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18together with sargramostim, aldesleukin, and isotretinoin after autologous stem celltransplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18,can block tumor growth in different ways. Some block the ability of tumor cells to grow andspread. Others find tumor cells and help kill them or carry tumor-killing substances tothem. Colony-stimulating factors, such as sargramostim, may increase the number of immunecells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white bloodcells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normalcells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 together withsargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be aneffective treatment for neuroblastoma.

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  • Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant

    This phase II trial is studying how well etanercept works in treating young patients withidiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept maybe effective in treating patients with idiopathic pneumonia syndrome after undergoing adonor stem cell transplant.

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  • Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

    This phase II trial is studying the side effects of and how well alisertib works in treatingyoung patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop thegrowth of cancer cells by blocking some of the enzymes needed for cell growth.

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  • A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

    This study is to evaluate the safety and clinical activity of idelalisib alone and incombination with rituximab in patients with CLL or SLL.

    This Phase 2 study will be the first time that idelalisib is administered to previouslyuntreated patients with hematologic malignancies. Idelalisib has demonstrated clinicalactivity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity,which supports its evaluation in previously untreated patients. The study population islimited to patients over 65 years of age because younger patients are generally appropriatefor standard immunochemotherapy regimens that are highly active. Since the mechanism ofaction of idelalisib is distinct from rituximab, it is hypothesized that the combinationwill be more active than either agent alone. This study will establish initial safety andclinical activity of idelalisib in combination with rituximab in patients with CLL or SLL.Cohort 2 of this study will establish safety and clinical activity of idelalisib alone insubjects with untreated CLL or SLL.

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  • A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.

    Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for thetreatment of pediatric patients 1 to 21 years old with relapsed or refractory acutelymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use isbased on the induction of complete responses. Randomized trials demonstrating increasedsurvival or other clinical benefit have not been conducted.

    The purpose of the phase 1 portion of this study was to determine if clofarabine added to acombination of etoposide and cyclophosphamide is safe in children with relapsed orrefractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). Thepurpose of the phase 2 portion of the study was to measure the effectiveness of thecombination therapy in children with ALL.

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  • A Multicenter, Open-label Study of CMX001 Treatment of Serious Diseases or Conditions Caused by dsDNA Viruses

    CMX001 is an orally administered lipid conjugate of the synthetic nucleotide analogcidofovir (CDV). The conjugate is believed to be absorbed in the small intestine thendelivered to target organs throughout the body where it crosses cell membranes byfacilitated and passive diffusion. Inside the cell, CMX001 is cleaved by intracellularphospholipases to release CDV which is converted to the active antiviral agent,CDV-diphosphate (CDV-PP), by intracellular anabolic kinases. Adults and adolescents,regardless of viral infection/disease, will have a maximum weekly dose of 200 mg i.e., 200mg once weekly OR 100 mg twice weekly; not to exceed 4mg/kg total weekly dose. Pediatricsubjects (< 12 years), regardless of viral infection/disease, will have a maximum weeklydose of 4 mg/kg i.e., 4 mg/kg once weekly OR 2 mg/kg twice weekly.

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  • Phase II Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia

    The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will beevaluated on the basis of response rate, when administered to patients with aggressivesystemic mastocytosis (ASM) or mast cell leukemia (MCL)

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  • Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

    To determine if Rituximab administered after allogeneic transplantation decreases theincidence of chronic GvHD

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  • A Multicenter Phase 2 Study of PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

    An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine KinaseInhibitor PCI-32765 (Ibrutinib) in Patients with Relapsed or Refractory Chronic LymphocyticLeukemia or Small Lymphocytic Lymphoma with 17p Deletion

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  • Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

    This randomized pilot clinical trial studies giving acupuncture in reducing nausea andvomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at anacupuncture point on the inside of the wrist may help control nausea and vomiting duringchemotherapy.

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  • Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

    This study assesses the long-term safety and tolerability of dasatinib administered topatients with chronic myelogenous leukemia or Philadelphia chromosome positive acutelymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib orimatinib in previous protocols.

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  • Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia

    This phase I/II clinical trial is studying the side effects and best dose of gamma-secretaseinhibitor RO4929097 and to see how well it works in treating young patients with relapsed orrefractory solid tumors, CNS tumors, lymphoma, or T-cell leukemia. Gamma-secretase inhibitorRO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed forcell growth.

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  • Sorafenib (BAY 43-9006) to Treat Children With Solid Tumors or Leukemias

    Background:

    - Sorafenib is an experimental anti-cancer drug that works by blocking proteins thoughtto be important for tumor growth. It has blocked the growth of tumors in test tubes andin some animal models.

    - Sorafenib is approved for the treatment of advanced kidney cancer.

    - This is the first time sorafenib is being tested in children with cancer.

    Objectives:

    - To determine the highest dose of sorafenib that can be safely given to children andyoung adults with cancer.

    - To determine the side effects and benefits, if any, of sorafenib in children and youngadults with cancer.

    - To study how the body handles sorafenib and the drug's effects on cells and proteins inthe blood.

    Eligibility:

    -Patients between 2 and 21 years of age with solid tumors or leukemias that do not respondto standard treatment.

    Patients between 2 and 21 years of age with AML and FLT3-ITD mutation for Part C of thestudy.

    Design:

    - Patients take sorafenib tablets every day about every 12 hours in 28-day treatmentcycles for a maximum of 24 cycles.

    - The dose is increased in succeeding groups of 3 to 6 children until serious sideeffects occur. Subsequent patients then receive the drug at lower doses.

    - Patients have a physical exam, blood and urine tests, and CT or MRI scans periodicallyto monitor safety and treatment effects. Leukemia patients also have bone marrowaspirates. Patients with a solid tumor may have an MRI. Children whose bones are stillgrowing have X-rays of the lower legs periodically to monitor bone structure.

    - Patients have additional blood studies to determine the amount of sorafenib in theblood, the effect of the drug on proteins and cells in the blood, and geneticdifferences that affect how individuals respond to the drug.

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  • A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)

    This is a randomized, double-blind, placebo-controlled study to assess the safety andtolerability of V212 when administered to adults with solid tumor malignancy (STM) orhematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpeszoster (HZ) in adults with STM or HM, as compared to placebo.

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  • Haploid Allogeneic Transplant Using the CliniMACS System

    To assess the proportion of patients with donor neutrophil engraftment within 30 days ofallogeneic transplant. To assess the incidence of acute GvHD during the first 100 days aftertransplantation.

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  • Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

    RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harmingnormal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has notresponded to chemotherapy, surgery or radiation therapy.

    PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not respondedto treatment.

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  • Efficacy and Safety of Midostaurin in Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia

    This study will investigate if the drug midostaurin taken orally twice daily is effectiveand safe in treating patients with aggressive systemic mastocytosis or mast cell leukemiawith or without an additional hematological neoplasm.

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  • Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts

    The primary objective of this study is to compare overall survival (OS) in patientsreceiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in apopulation of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30%bone marrow blasts) who have failed azacitidine or decitabine treatment. This patientpopulation has no available therapy and a short life expectancy (approximately 4 months).The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studieshas the potential to delay substantially the transition of MDS to Acute MyeloidLeukemia(AML), a very significant and severe complication, which shortens survival of theseMDS patients.

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  • Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL

    This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, andpharmacokinetics of tamibarotene in adult patients with relapsed or refractory acutepromyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) andarsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO.Treatment may have been administered either as combination therapy or sequentially as singleagents. Patients who are intolerant to either drug are eligible for this study.

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  • Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

    The purpose of the study is to evaluate the overall and disease free survival of recipientswho have received G-CSF mobilized stem cells from HLA matched sibling donors.

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  • Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors

    This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors inhumans.

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  • Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors

    RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan,work in different ways to stop the growth of tumor cells, either by killing the cells or bystopping them from dividing. Giving more than one drug (combination chemotherapy) may killmore tumor cells.

    PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan whengiven together with temozolomide and vincristine in treating young patients with refractorysolid tumors.

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  • Phase 1 Trial of Oral Ixabepilone

    This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) andsafety of this dosing schedule in participants with advanced cancer

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  • Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors

    This study aims to investigate and optimize imaging sequences and parameters of rapidreal-time MRI in order to obtain adequate guidance for accurately and precisely deliveringradiation to moving abdominal and thoracic tumors.

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  • F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

    The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CTscanning to that of conventional bone scanning for detecting cancer that has spread to thebone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CTwill lead to improved treatment and patient outcomes.

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  • S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumorcells, either by killing the cells or by stopping them from dividing. Measuring blood levelsof tumor cells may help in learning how well chemotherapy works to kill metastatic breastcancer cells and allow doctors to plan better treatment. When blood levels of tumor cellsare high while receiving chemotherapy, it is not yet known whether it is more effective tochange chemotherapy regimens at that time or wait until disease progression.

    PURPOSE: This randomized phase III trial is studying treatment decision making based onblood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.

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  • Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders

    The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir willresult in complete or partial responses in patients with EBV-positive lymphoid malignanciesor lymphoproliferative disorders.

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  • Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

    This phase I trial is studying the side effects and best dose of vorinostat when giventogether with isotretinoin in treating young patients with recurrent or refractory solidtumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work indifferent ways to stop the growth of cancer cells, either by killing the cells or bystopping them from dividing. Vorinostat may also stop the growth of cancer cells by blockingsome of the enzymes needed for cell growth and by blocking blood flow to the cancer.Isotretinoin may cause cancer cells to look more like normal cells, and to grow and spreadmore slowly. Giving vorinostat together with isotretinoin may be an effective treatment forcancer.

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  • LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

    A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd willcontinue until the patient experiences unacceptable toxicity that precludes furthertreatment, discontinues treatment at the discretion of the investigator or patient, starts anew anti-cancer therapy and/or dies. LDK378 may be continued beyond RECIST-defined PD asassessed by the investigator if, in the judgment of the investigator, there is evidence ofclinical benefit. In these patients tumor assessment should continue as per the schedule ofassessments until treatment with LDK378 is permanently discontinued. Patients whodiscontinue the study medication in the absence of progression will continue to be followedfor tumor assessment until the time of PD as assessed by the investigator

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  • A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

    This multicenter, randomized, double-blind, placebo-controlled study will evaluate theefficacy and safety of RO5490258 (MetMab) in combination with either of two backbonechemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IVnon-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum(cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-daycycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum(cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-daycycle. Patients who have not progressed after 4 cycles will be offered maintenance therapywith their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) orpemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment isuntil disease progression or unacceptable toxicity occurs.

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  • Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia

    This randomized phase III trial studies cytarabine and daunorubicin hydrochloride oridarubicin and cytarabine with or without vorinostat to see how well they work in treatingyounger patients with previously untreated acute myeloid leukemia. Drugs used inchemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat,work in different ways to stop the growth of cancer cells, either by killing the cells,stopping them from dividing, or by stopping from spreading. Giving more than one drug(combination chemotherapy) and giving the drugs in different doses and in differentcombinations may kill more cancer cells. It is not yet known which combination chemotherapyis more effective in treating acute myeloid leukemia.

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  • Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase II clinical trial studies how well dasatinib followed by stem cell transplantworks in treating older patients with newly diagnosed acute lymphoblastic leukemia.Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed forcell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancercells by stopping them from dividing or killing them. Monoclonal antibodies, such asalemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving morethan one drug (combination chemotherapy) and giving dasatinib together with chemotherapy maykill more cancer cells.

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  • A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme

    The primary objective of this Phase II study is to evaluate the progression-free survival at6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who aretreated with MEDI-575.

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  • Cancer: Thriving and Surviving Online Workshop and Study for Cancer Survivors

    Cancer: Surviving and Thriving is a 6-week workshop for cancer survivors. The overall goalof the study is to determine whether an online cancer survivor education and supportworkshop can have lasting beneficial effects in helping survivors improve theirself-management of health skills and quality of life.

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  • Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma

    Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetictesting may help predict how cancer will respond to treatment and allow doctors to plan moreeffective therapy.

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  • Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

    The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of carechemotherapy, with less than 30% survival. Based on recent encouraging pediatric literaturewe have designed this trial to improve the outcome of patients with metastatic Ewingssarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

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  • Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividingso they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumorcells. Peripheral stem cell transplantation may allow the doctor to give higher doses ofchemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy ismore effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

    PURPOSE: This randomized phase III trial is studying different combination chemotherapyregimens to see how well they work when given with or without peripheral stem celltransplantation, radiation therapy, and/or surgery in treating patients with Ewing'ssarcoma.

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  • Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

    This phase III trial is studying how well combination chemotherapy and radiation therapywork in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used inchemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in differentways to stop tumor cells from dividing so they stop growing or die. Radiation therapy useshigh-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy maykill more tumor cells. It is not yet known which treatment regimen is more effective intreating low-risk rhabdomyosarcoma.

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  • ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Metastatic Bone Tumors for the Palliation of Pain

    A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of MetastaticBone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are notCandidates for Radiation Therapy

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  • Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma

    RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stopthe growth of tumor cells, either by killing the cells or by stopping them from dividing.

    PURPOSE: This phase II trial is studying how well cytarabine works in treating youngpatients with recurrent or refractory Ewing's sarcoma.

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  • Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma

    This phase II trial study has a 6-patient feasibility portion studying the tolerability ofchemotherapy with vincristine sulfate together with topotecan hydrochloride,cyclophosphamide, and bevacizumab in treating young patients with refractory or firstrecurrent extracranial Ewing's sarcoma. If the therapy is considered tolerable, thisfeasibility run-in will be followed by a randomized phase II portion studying givingvincristine sulfate together with topotecan hydrochloride, and cyclophosphamide to see howwell it works compared with giving vincristine sulfate together with topotecanhydrochloride, cyclophosphamide, and bevacizumab in treating young patients with refractoryor first recurrent extracranial Ewing's sarcoma. Drugs used in chemotherapy, such asvincristine sulfate, topotecan hydrochloride, and cyclophosphamide, work in different waysto stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in differentways. Some block the ability of tumor cells to grow and spread. Others find tumor cells andhelp kill them or carry tumor-killing substances to them. Bevacizumab may also stop tumorgrowth by blocking blood flow to the tumor. Giving combination chemotherapy together withbevacizumab may kill more tumor cells.

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  • Trial of Dasatinib in Advanced Sarcomas

    This study will examine the response rate and the 6-month progression-free survival rates ofsubjects with advanced sarcoma treated with dasatinib.

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  • Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

    The purpose of this study is to document the additional detection of papillary bladdercancer and the reduced early recurrence due to the improved detection and resection of thesetumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillarybladder cancer.

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  • DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

    This study is being conducted to examine survival, safety, and the magnitude of the immuneresponse induced following administration of DN24-02 in subjects with HER2+ urothelialcarcinoma.

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  • Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

    This is a multi-institutional, randomized trial evaluating oncologic, perioperative, andfunctional outcomes following two standard care procedures for radical cystectomy. Theparticipants will have one of the standard care procedures as part of their care. The twoprocedures that will be followed are open radical cystectomy and robotic assisted radicalcystectomy (RARC). Open cystectomy is considered to be the more traditional approach. Whilenewer, RARC is considered to be equivalent to open surgery when it is performed by a trainedrobotics surgeon. The reported complication rates of RARC appear comparable to open surgery.This means there is no significant difference in the risk between the two standardprocedures. However, despite these potential advantages, true comparison between the openand robotic technique with regards to long term cancer related and functional outcomes hasnot been accomplished because previous studies did not compare patients of equal healthstatus. The researchers hope to learn whether or not patients undergoing RARC recover morequickly than or at the same rate as patients undergoing an open radical cystectomy whilehaving non inferior cancer related outcomes. This study is funded by the National Institutesof Health (NIH).

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  • Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer

    This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine andCisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out whichtreatment is better.

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  • Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

    The study is intended to investigate whether the improved initial detection and resection ofbladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix(Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrencescompared to standard white light cystoscopy/TURB.

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  • Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients

    The purpose of this study is to compare treatment methods and outcomes of patients diagnosedwith acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

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  • ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain

    A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal BoneSystem in the treatment of pain resulting from metastatic bone tumors.

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  • Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas

    This is a research study of patients with diffuse intrinsic pontine gliomas. We hope tolearn about the safety and efficacy of treating pediatric diffuse intrinsic pontine gliomapatients with the EGFRvIII peptide vaccine after conventional radiation.

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  • Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma

    This phase II trial studies how well sunitinib malate works in treating younger patientswith recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malatemay stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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  • Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma

    This randomized phase II trial studies how well low-dose lenalidomide works compared withhigh-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas oroptic nerve pathway gliomas that have come back (recurrent), have not responded to treatment(refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide maystop the growth of tumor cells by blocking blood flow to the tumor. It is not yet knownwhether low-dose lenalidomide is more or less effective than high-dose lenalidomide intreating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.

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  • Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

    We hope to determine the maximum tolerated dose of 3 session (i.e., treatment) stereotacticradiosurgery to treat brain metastases greater than 4.2 cm3 in size. By increasing radiationdose, we will determine if there is a better outcome without greater toxicity (side effects)for patients.

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  • A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

    This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients thatare newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory orrelapsed Ph+ ALL compared to the adult populations. It will also evaluate safety andactivity of nilotinib as secondary objectives.

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  • Haploidentical Allogeneic Transplant w/Post Transplant Infusion of Regulatory T-cells (BMT Protocol 204)

    When a match related or matched unrelated donor is not available a Haploidentical donor(parent, sibling or child)is immediately available. The challenges associated withhaploidentical HCT include increased risk of GVHD, graft rejection and impaired immunereconstitution. This trial will evaluate the safety and feasibility of simultaneousadministration of conventional T cells and regulatory T cells after haploidenticalallogeneic hematopoietic cell transplantation to overcome these challenges.

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  • Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

    This randomized phase II/III trial studies how well azacitidine works with or withoutlenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromesor chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work indifferent ways to stop the growth of cancer cells, either by killing the cells, stoppingthem from dividing, or by stopping them from spreading. Lenalidomide may stop the growth ofcancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancercells by blocking some of the enzymes needed for cell growth. It is not yet known whetherazacitidine is more effective with or without lenalidomide or vorinostat in treatingmyelodysplastic syndromes or chronic myelomonocytic leukemia.

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  • Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

    This randomized phase II trial studies azacitidine with or without entinostat to see howwell they work compared to azacitidine alone in treating patients with myelodysplasticsyndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. Drugs used inchemotherapy, such as azacitidine, work in different ways to stop the growth of cancercells, either by killing the cells, by stopping them from dividing, or by stopping them fromspreading. Entinostat may stop the growth of cancer cells by blocking some of the enzymesneeded for cell growth. Giving azacitidine together with entinostat may work better intreating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acutemyeloid leukemia.

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  • ON 01910.Na for Intermediate1-2, or High Risk Trisomy 8 Myelodysplastic Syndrome (MDS)

    This is a phase 2 single arm study in which fourteen MDS patients with Trisomy 8 orclassified as Intermediate-1, 2, or High risk who meet all other inclusion/exclusioncriteria will receive ON 01910.Na 1800 mg/24h as an intravenous continuous infusion (IVCI)over 72 hours every other week for the first four 2-week cycles and every 4 weeksafterwards.

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  • Pilot Lenalidomide in Adult Diamond-Blackfan Anemia Patients w/ RBC Transfusion-Dependent Anemia

    This is a single-center, single arm, open-label study of oral lenalidomide monotherapyadministered to red blood cell (RBC) transfusion dependent adult subjects withDiamond-Blackfan Anemia (DBA).

    Primary Objective: To evaluate the erythroid response rate as measured by rate of red bloodcell transfusion independence (MDS IWG 2000 Criteria will be applied) Secondary Objective:1)To evaluate the tolerability and safety profile of lenalidomide in patients with DBA andother inherited marrow failure syndromes 2) To correlate response to lenalidomide withbiologic surrogates of DBA including ribosomal protein mutation status, ex vivo erythroidcolony growth, and microarray gene expression

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  • Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes

    This phase III trial is studying how well combination chemotherapy works in treating youngpatients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugsused in chemotherapy work in different ways to stop the growth of cancer cells, either bykilling the cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more cancer cells.

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  • A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia

    This is a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part3: extension), multi-center study to evaluate the effect of eltrombopag in subjects withmyelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopeniadue to bone marrow insufficiency from their underlying disease or prior chemotherapy. Thisobjective will be assessed by a composite primary endpoint that consists of the following:the proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, orplatelet transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bonemarrow insufficiency from their underlying disease or prior chemotherapy will be enrolled inthe study. No low or intermediate-1 risk MDS subjects will be enrolled in the study.

    Subjects must have had at least one of the following during the 4 weeks prior to enrolment:platelet count <10 Gi/L, platelet transfusion, or symptomatic hemorrhagic event. Supportivestandard of care (SOC), including hydroxyurea, will be allowed as indicated by localpractice throughout the study. The study will have 3 sequential parts. Subjects who areenrolled in Part 1 (open-label) cannot be enrolled in Part 2 of the study (randomized,double-blind); however, subjects who complete the treatment period for Part 1 or Part 2 (8and 12 weeks, respectively) will continue in Part 3 (extension) if the investigatordetermines that the subject is receiving clinical benefit on treatment.

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  • Azacitidine + Lenalidomide Combo in the Elderly Previously Treated Acute Myeloid Leukemia (AML) & High-Risk Myelodysplastic Syndromes (MDS)

    Primary Objective:

    - Determine the lack of disease progression (CR/CRi/PR/HI rate) after 6 cycles of treatmentwith the combination of azacitidine plus lenalidomide in previously treated patients withAcute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndromes (HR-MDS).

    Secondary Objective:

    - Determine the 42-day survival after treatment with this combination in elderly patientswith previously treated AML/HR-MDS patients

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  • CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

    This phase II clinical trial studies how well liposomal cytarabine-daunorubicin CPX-351(CPX-351) works in treating patients with relapsed or refractory acute myeloid leukemia ormyelodysplastic syndrome. Drugs used in chemotherapy, such as liposomalcytarabine-daunorubicin CPX-35, work in different ways to stop the growth of cancer cells,either by killing the cells or by stopping them from dividing.

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  • Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

    The study objective is to compare the efficacy and safety of US-ATG-F as a supplement tostandard of care prophylaxis versus standard of care prophylaxis alone in moderate to severechronic GVHD-free survival.

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  • MLN4924 for the Treatment of Acute Myelogenous Leukemia, Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia

    An open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients withacute myelogenous leukemia (AML), high-grade myelodysplastic syndrome (MDS). The patientpopulation will consist of adults previously diagnosed with AML including high-grade MDS forwhich standard curative, life-prolonging treatment does not exist or is no longer effective.

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  • Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia

    This randomized phase III trial studies lenalidomide to see how well it works with orwithout epoetin alfa in treating patients with myelodysplastic syndrome and anemia.Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to thecells. Colony stimulating factors, such as epoetin alfa, may increase the number of immunecells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide ismore effective with or without epoetin alfa in treating patients with myelodysplasticsyndrome and anemia.

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  • Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia

    Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential toaccelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection inpatients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloidleukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In thisstudy, the safety, tolerability and activity of CLT-008 administered after "standard ofcare" cytarabine-based consolidation or induction/re-induction chemotherapy will bedetermined by monitoring for adverse reactions, infusion reactions, graft-versus hostdisease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections andcomplications.

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  • Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

    The purpose of this study is to determine the tolerability and efficacy in treating patientsaged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) ormyeloproliferative disorders (MPD).

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  • Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

    RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used inchemotherapy, such as temozolomide and lomustine, work in different ways to stop the growthof tumor cells, either by killing the cells or by stopping them from dividing. Givingradiation therapy together with temozolomide and lomustine after surgery may kill anyremaining tumor cells.

    PURPOSE: This phase II trial is studying how well giving radiation therapy together withtemozolomide and lomustine works in treating young patients with newly diagnosed gliomas.

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  • Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

    This study is designed to evaluate the clinical activity of CDX-110 vaccination when givenwith standard of care treatment (maintenance temozolomide therapy). Study treatment will begiven until disease progression and patients will be followed for long-term survivalinformation. Efficacy will be measured by the progression-free survival status at 5.5 monthsfrom the date of first dose.

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  • Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas

    RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways tostop tumor cells from dividing so they stop growing or die. Radiation therapy useshigh-energy x-rays to damage tumor cells and may be an effective treatment for patients withglioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive toradiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumorcells.

    PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide withradiation therapy in treating patients who have newly diagnosed gliomas.

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  • Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme

    This, international, multi-center, Phase 2 study of verubulin will be conducted in patientswith newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in twoparts. Part A is an open-label dose finding study that will determine the safety andtolerability of verubulin in combination with standard treatment. Part B is a randomizedopen-label study that will investigate progression-free survival and overall survival ofpatients receiving verubulin, at the dose determined in Part A, in combination with standardtreatment versus standard treatment alone.

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  • Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

    The purpose of this study is to determine the safety and effectiveness of Azixa in patientswith recurrent glioblastoma multiforme

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  • Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

    This 2-arm, randomized, phase III study will investigate the efficacy and safety of theaddition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancereffects in patients who have tumors that express the EGFRvIII protein) to the currentstandard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type ofbrain cancer.

    All patients will be administered temozolomide, the standard treatment for glioblastoma.Half the patients will be randomly assigned to receive rindopepimut and half the patientswill be randomly assigned to receive a control called keyhole limpet hemocyanin.

    Patients will be treated in a blinded fashion (neither the patient or the doctor will knowwhich arm of the study the patient is on). Patients will be treated until diseaseprogression or intolerance to therapy and all patients will be followed for survival.

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  • Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors

    This molecular biology and phase II trial studies how well imetelstat sodium works intreating younger patients with recurrent or refractory brain tumors. Imetelstat sodium maystop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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  • Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

    RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness andimprove the quality of life of patients with excessive daytime sleepiness after cancertherapy. It is not yet known whether methylphenidate hydrochloride or modafinil are moreeffective than a placebo in reducing daytime sleepiness in these patients.

    PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride ormodafinil to see how well they work compared with a placebo in treating young patients withexcessive daytime sleepiness after cancer therapy.

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  • Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma

    The goal of this clinical research study is to learn if the combination of Avastin(bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients.The safety of this drug combination will also be studied.

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  • Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors

    RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiationtherapy. It is not yet known if memantine is effective in preventing side effects caused bywhole-brain radiation therapy.

    PURPOSE: This randomized phase III trial is studying memantine to see how well it workscompared to a placebo in preventing side effects caused by whole-brain radiation therapy inpatients with brain metastases from solid tumors.

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  • Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used inchemotherapy work in different ways to stop tumor cells from dividing so they stop growingor die. It is not yet known whether radiation therapy alone is as effective as chemotherapyplus radiation therapy in treating germ cell tumor.

    PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how wellit works compared to chemotherapy and radiation therapy in treating patients with newlydiagnosed primary CNS germ cell tumor.

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  • Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors

    RATIONALE: Drugs used in chemotherapy, such as valproic acid, work in different ways to stopthe growth of tumor cells, either by killing the cells or by stopping them from dividing.Valproic acid may also stop the growth of solid tumors or CNS tumors by blocking blood flowto the tumor.

    PURPOSE: This phase I trial is studying the side effects and best dose of valproic acid intreating patients with recurrent or refractory solid tumors or CNS tumors.

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  • Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

    RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.

    PURPOSE: This phase II trial is studying how well avoiding the hippocampus duringwhole-brain radiation therapy works in treating patients with brain metastases.

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  • Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer

    The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostatgiven concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer(NSCLCA) brain metastases in patient with 1-4 lesions.

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  • A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

    This study will compare the efficacy, in terms of complete responses and overall survival,of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

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  • Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

    Nelarabine has shown significant activity in patients with T-cell malignancies. This studywill determine the safety and maximum tolerated dose of the combination of nelarabine,cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or firstrelapse of T-LL.

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  • T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

    Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treatingchildren (age 1-21) with leukemia. This research study will use clofarabine with two othercancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16)and cyclophosphamide (Cytoxan®).

    Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study tofind out the highest doses of these drugs that can be safely given to children with relapsedor refractory leukemia. This study is a phase II study which will use the drugs to study howwell these drugs work against AML. This study will also examine the safety of this drugcombination.

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  • ABT-751 With Chemotherapy for Relapsed Pediatric ALL

    This is a phase I/II study of an investigational drug called ABT-751, produced by AbbottLaboratories, given in combination with chemotherapy drugs used to treat acute lymphoblasticleukemia (ALL) that has come back (recurred). The phase I portion of this study is beingdone to find the highest dose of ABT-751 that can be given safely in combination with otherchemotherapy drugs. A safe dose is one that does not result in unacceptable side effects.After a safe dose for ABT-751 given with chemotherapy has been found, the study will addadditional patients to find out if ABT-751 (given at the maximal safe dose) when given withadditional chemotherapy is an effective therapy for the treatment of children with relapsedALL. It is expected that approximately 15-35 children and young adults will take part inthis study.

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  • Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

    This is a Phase I/II study of a drug called bortezomib given in combination withchemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back(recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration(FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomibhas been shown to cause cancer cells to die in studies done on animals (mice). Studies havebeen done that have shown that some adults and children with cancer have shown a response tobortezomib when it is used alone. Studies have also been done in adults to evaluate the doseof bortezomib that can be safely given in combination with other chemotherapy drugs.

    The Phase I portion of this study is complete and the dose for the phase II portion of thestudy is 1.3mg/m2/day. The phase II portion of the study is open and accruing.

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  • A Phase I Study of AC220 for Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

    This is a phase I study of the investigational drug AC220 combined with cytarabine andetoposide in patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenousleukemia (AML).

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  • A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

    This is a pilot study using decitabine and vorinostat before and during chemotherapy withvincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients withacute lymphoblastic leukemia (ALL).

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  • A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

    This is a phase I study of temsirolimus (Torisel) combined with dexamethasone,cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL),lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

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  • Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

    The purpose of this study is to determine whether Dasatinib when added to standardchemotherapy is effective and safe in the treatment of pediatric philadelphia chromosomepositive acute lymphoblastic leukemia

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  • A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)

    A Phase 2, Open-Label, Multicenter study evaluating the preliminary efficacy and safety ofABT-199 administered orally in patients with AML.

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  • Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

    This phase II trial studies how well cilengitide works in treating younger patients withrecurrent or progressive high-grade glioma that has not responded to standard therapy.Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

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  • Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

    This randomized phase III trial is studying different combination chemotherapy regimens andtheir side effects and comparing how well they work in treating young patients with newlydiagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs usedin chemotherapy work in different ways to stop the growth of cancer cells, either by killingthe cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapyregimen is more effective in treating T-cell acute lymphoblastic leukemia or T-celllymphoblastic lymphoma.

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  • Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML

    Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects olderadults. Even with the best chemotherapy, two-year disease-free survival is achieved in aminority of patients. Bone marrow transplantation from a sibling donor may improve curerates; however, patients over 50 years of age have a high risk of complications andtherefore generally are excluded from this treatment option. Recently our group developed atransplantation strategy for older cancer patients that protects againsttransplant-associated complications, yet does not interfere with the ability of thetransplanted donor cells to destroy cancer cells. With this new method, we can now safelyevaluate transplantation as a curative therapy for AML patients over the age of 50. We haveassembled clinical and scientific researchers throughout the state of California to studyand compare bone marrow transplantation using our new approach with the best standard ofcare chemotherapy in AML patients over the age of 50. The results of this study have thepotential to establish a new treatment standard that will improve survival of older AMLpatients.

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  • Allogeneic Transplantation From Related Haploidentical Donors in Older Patients With Indolent Hematologic Malignancies

    The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+selected hematopoietic cells from a haploidentical related donor following anonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin(ATG).

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  • Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies

    To measure how frequently and to what degree a complication of transplant cell acute graftversus host disease (GV/HD) occurs.

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  • Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas

    A safety & efficacy clinical study of the investigational medicinal product BYM338 for thetreatment of unintentional weight loss in patients with cancer of the lung or the pancreas

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  • Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia

    To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients(60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpointwill be overall survival.

    Investigator

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  • A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung

    The purpose of this study is to determine how long patients who undergo complete surgicalremoval of recurrent osteosarcoma in the lung will remain free of cancer after takingSaracatinib compared to patients taking placebo (a sugar pill).

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  • Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

    This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, andbevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatinin treating patients with urinary tract cancer that has spread to other places in the body.Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work indifferent ways to stop the growth of tumor cells, either by killing the cells, by stoppingthem from dividing, or by stopping them from spreading. Monoclonal antibodies, such asbevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yetknown whether gemcitabine hydrochloride and cisplatin are more effective when given with orwithout bevacizumab in treating patients with urinary tract cancer.

    Investigator

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  • Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

    PRIMARY OBJECTIVES:

    Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD.

    SECONDARY OBJECTIVES:

    Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD.

    Investigators

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  • A Study of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma

    This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administeredby intravenous (IV) infusion to patients with relapsed or refractory hematologicmalignancies. In addition, at selected sites, DCDT2980S will be studied in combination withrituximab.

    Investigator

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  • Phase IIa Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

    Intrapatient dose escalation of desipramine. Start at 75 mg daily. Increase by 75 mg weeklyto maximum of 450 mg daily. Taper desipramine upon disease progression, unacceptabletoxicity or patient withdrawal from study.

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  • Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer

    The purpose of this study is to evaluate the objective tumor response rate to SNS-595 inpatients with small cell lung cancer (SCLC).

    Investigator

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  • Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

    The purpose of this study is to determine the best confirmed response rate of dailyadministration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR andVEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment witheither erlotinib or gefitinib.

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  • Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

    Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annuallycauses 150,000 deaths in the US and greater than 1 million worldwide. The standard treatmentfor early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are pooroperative candidates or decline surgery. An emerging alternative is Stereotactic BodyRadiation Therapy (SBRT). Mounting evidence from Phase I/II studies demonstrates that SBRToffers excellent local control. Most SBRT trials focused on small, peripheral tumors ininoperable patients. Increasingly, clinical trials study SBRT in operable patients, oftenwith larger, central tumors.

    Using clinical staging, a significant proportion of patients harbor occult nodal metastaseswhen undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higherrisk of nodal metastases. These nodal metastases frequently would be removed by surgicalintervention. However, SBRT, at present, is only directed at the primary tumor, potentiallyleading to regional failures in otherwise curable patients. To increase the effectiveness ofSBRT for lung tumors, the next logical step is to explore whether the highest risk areas ofdisease spread can be identified and targeted. Regional failure could be reduced and outcomeimproved in a significant proportion of patients treated with SBRT if the primary nodaldrainage (PND) were identified, targeted and treated in addition to the primary tumor.

    We propose to conduct a study to determine how well water soluble iodinated contrastmaterial when injected directly into the tumor can be visualized on CT scan and integratedinto radiation therapy treatment planning.

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  • Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation

    Patients treated with radiation therapy for lung tumors can experience inflammation aftertreatment. This study hopes to evaluate the use of breath analysis to evaluate changes inthe composition of exhaled breath in patients undergoing radiotherapy. If changes can bedetected, this may ultimately serve as biomarkers for identifying patients at highest riskfor radiation-induced lung injury (radiation pneumonitis).

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  • BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

    RATIONALE: Vaccines may help the body build an effective immune response to kill tumorcells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.Some block the ability of tumor cells to grow and spread. Others find tumor cells and helpkill them or carry tumor-killing substances to them. Drugs used in chemotherapy work indifferent ways to stop the growth of tumor cells, either by killing the cells or by stoppingthem from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Givingvaccine therapy together with bevacizumab after chemotherapy and radiation therapy may killmore tumor cells.

    PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccinetogether with bevacizumab after chemotherapy and radiation therapy in treating patients withnewly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removedby surgery.

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  • Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers

    This pilot clinical trial studies cognitive behavioral therapy in treating anxiety inpatients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioraltherapy may reduce anxiety and improve the well-being and quality of life of patients whohave stage IV non-small cell lung cancer and their caregivers.

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  • A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

    This multicenter, randomized, double-blind, placebo-controlled study will evaluate theefficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum inpatients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo onDay 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv andplatinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have notprogressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo asmaintenance therapy until disease progression or unacceptable toxicity occurs.

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  • CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer

    The purpose of this study is to assess the short and long-term outcomes after CyberKnifestereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients whoare medically inoperable.

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  • Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

    This randomized phase II trial studies how well giving erlotinib hydrochloride andcabozantinib-s-malate alone or in combination works as second or third line therapy intreating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride andcabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymesneeded for cell growth. It is not yet known whether giving erlotinib hydrochloride togetherwith cabozantinib-s-malate is more effective than erlotinib hydrochloride orcabozantinib-s-malate alone in treating non-small cell lung cancer.

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  • Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

    This study is primarily designed to assess the safety and tolerability of AZD4547 atincreasing doses in patients with advanced solid malignancies and for whom no standardmedication options are available. It also assesses the blood levels and action of AZD4547 inthe body over a period of time.

    Investigator

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  • A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer

    The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makesthe cancer treatment more effective in patients with locally advanced or metastaticnon-small cell lung cancer

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  • An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

    This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versuspemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specificgene profile involving the ALK gene after failure of one previous chemotherapy regimen thatincluded one platinum drug.

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  • An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

    This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 inpatients with advanced non-small cell lung cancer with a specific gene profile involving theALK gene. This trial will also allow patients from a Phase 3 trial who received standard ofcare chemotherapy (Study A8081007) to receive PF-02341066.

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  • Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

    The purpose of this study is to assess how well this particular combination of chemotherapy,radiation and surgery works to help people with locally advanced lung cancer, how well PETscans indicates whether someone has responded to chemotherapy and radiation, and geneexpression patterns related to outcomes in patients with locally advanced lung cancer whoreceive this treatment regimen.

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  • A Study of XL184 (Cabozantinib) With or Without Erlotinib in Adults With Non-Small Cell Lung Cancer

    In Phase 1 of this study, the purpose is to evaluate the safety, tolerability, and highestsafe dose of the multiple receptor tyrosine kinase inhibitor (including VEGFR2, MET, andRET) XL184 in combination with the EGFR inhibitor erlotinib administered to adults withNon-Small-Cell Lung Cancer (NSCLC). In Phase 2 of this study, the purpose is to evaluate theobjective response rate of daily oral administration of XL184 with or without erlotinib insubjects with NSCLC who have progressed after responding to treatment with erlotinib.

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  • Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer

    RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent thedevelopment or recurrence of cancer. It is not yet known if selenium is effective inpreventing the growth of new tumors in patients with previously resected non-small cell lungcancer.

    PURPOSE: This randomized phase III trial is studying selenium to see how well it workscompared to a placebo in preventing the development of second primary lung tumors inpatients who have undergone surgery to remove stage I non-small cell lung cancer.

    Investigator

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  • Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    The purpose of this study is to evaluate progression-free survival among subjects with KRASmutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib(ARQ 197) compared to single agent chemotherapy.

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  • Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

    In this research study erlotinib will be given to eligible participants whose lung cancerhas been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lungcancer, and must have 1 or more of the following characteristics: be female, be of Asian orPacific Rim descent and/or be a never smoker. The potential participant's tumor will beexamined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that isoverexpressed in most non-small cell lung cancers. Some EGFR has been found to have specificmutations and the participant must have one of these mutations in his tumor.

    Erlotinib blocks this protein and may control tumor growth and increase survival. Previousresearch has shown that erlotinib is most effective for people who have these specificmutations in the EGFR.

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  • PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer

    RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop thegrowth of tumor cells, either by killing the cells or by stopping them from dividing.

    PURPOSE: This phase II trial is studying how well PR-104 works in treating patients withpreviously untreated or relapsed small cell lung cancer (SCLC).

    Investigator

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  • Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer

    Lung cancer remains the most frequent cause of cancer death in both men and women in theworld. Surgical resection using lobectomy with mediastinal lymph node dissection or samplinghas been a standard of care for operable early stage NSCLC. Several studies have reportedhigh local control and survival using SBRT in stage I NSCLC patients. SBRT is now anaccepted treatment for medically inoperable patients with stage I NSCLC and patients withoperable stage I lung cancer are entered on clinical protocols. The purpose of this study isto conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the currentstandard of care for stage I operable NSCLC.

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  • Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

    RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to thetumor and cause less damage to normal tissue near the tumor.

    PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy worksin treating patients with stage I or stage II non-small cell lung cancer that can be removedby surgery.

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  • Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer

    This randomized phase II trial is studying how well giving carboplatin and paclitaxeltogether with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stageIIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatinand paclitaxel, work in different ways to stop the growth of tumor cells, either by killingthe cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab andcixutumumab, can block tumor growth in different ways. Some block the ability of tumor cellsto grow and spread. Others find tumor cells and help kill them or carry tumor-killingsubstances to them. Giving chemotherapy together with monoclonal antibody therapy may killmore tumor cells. It is not yet known whether carboplatin and paclitaxel are more effectivewhen given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.

    Investigator

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  • An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed

    This large, non-randomized observational study is being conducted to provide data about theimpact of ethnic origin on outcomes and resource utilization during the 2nd line treatmentof non-small cell lung cancer (NSCLC) in a routine medical care setting.

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  • CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

    This study is designed to test whether CT-2103/carboplatin provides improved overallsurvival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels>30 pg/ml.

    Investigator

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  • Phase II Trial of Bevacizumab in Combination With Pemetrexed as 2nd Line Therapy in Patients With Stable Brain Metastases From Non-small Cell Lung Cancer

    This study seeks to evaluate the safety of combining bevacizumab and pemetrexed in non-smallcell lung cancer (NSCLC) patients with stable brain metastases as second line chemotherapy,while also looking for an improvement in progression free survival (PFS) as well as overallsurvival.

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  • A Phase I/II Study of Bexarotene in Combination With ZD1839 (IRESSA®) in the Treatment of Non-Small Cell Lung Cancer

    The purpose of Phase 1 of this study is to evaluate the safety of the combination regimen,bexarotene and ZD1839. Phase II will evaluate the median survival, time to diseaseprogression, and toxicity.

    Investigator

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  • Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yetknown if giving radiation therapy to the head is effective in preventing CNS metastases inpatients who have stage III non-small cell lung cancer.

    PURPOSE: This randomized phase III trial is studying how well radiation therapy to the headworks in preventing CNS metastases in patients who have been previously treated for stageIII non-small cell lung cancer.

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  • Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer

    RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinasein vitro and in vivo, with significant dose-dependent, anti-tumor activity in four differenthuman tumor types including colon, pancreatic, lung, and ovarian. This activity wascytostatic in nature and was maintained if dosing was continued. That is, tumor growth issuspended while the drug is administered but returns to baseline rates when the agent iswithdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess theactivity of sorafenib in a timely manner and with a meaningful interpretation, a randomizeddiscontinuation design was adopted in the present trial, conducted in a population who werepotentially sensitive to sorafenib.

    PURPOSE: This randomized phase II trial is studying sorafenib to see how well it workscompared to placebo in treating patients with refractory non-small cell lung cancer.

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  • Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status

    RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly tothe tumor may kill more tumor cells and cause less damage to normal tissue.

    PURPOSE: This phase I trial is studying the side effects and best dose of specializedradiation therapy in treating patients with stage II, stage III, stage IV, or recurrentnon-small cell lung cancer and poor performance status.

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  • A Study of Enzastaurin and Erlotinib in Patients With Solid Tumors and Lung Cancer

    Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated bypatients with solid tumor cancer.

    Phase II: A study to see how long patients with non-small cell lung cancer treated withEnzastaurin and Erlotinib live

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  • GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

    The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeuticproduct GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal oftheir tumor. A course of 13 injections will be administered over 27 months. The ProtocolPosting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

    Investigator

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  • A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC).

    The purpose of the study is to see if sorafenib plus best supportive care (i.e. in additionto the non-cancer treatments patients would normally receive) is an effective treatment forlung cancer compared to best supportive care alone. The safety and tolerability of the twotreatment groups will also be compared. The goal of the study is to test the ability ofsorafenib to improve survival compared to best supportive care alone.

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  • Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations

    The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) toerlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this researchstudy is to learn more about NSCLC and how it may respond to study treatment. Erlotinib(Tarceva) is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a proteincalled the epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumorcell survival. However, although TKI drugs can work for some lung cancer patients for aperiod of time, eventually the tumor finds a way to resist or counteract the TKI treatmentand it begins to grow again. Hydroxychloroquine (HCQ) is a drug approved by the FDA fortreating malaria, rheumatoid arthritis, and several other diseases. Laboratory researchsuggests that when HCQ is given with a TKI, it may help delay or prevent TKI resistance fromdeveloping.

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  • Phase I Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)

    This phase I trial studies the side effects and best dose of giving erlotinib and dovitinibtogether to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks theepidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancerand dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets whichmay be important to treat lung cancer. The combination of both drugs may work better thaneither drug alone, but may also have increased side effects. This trial will look at theside effects of combining the drugs and look for how effective the combination may be.

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  • Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer

    This phase I trial studies how well talactoferrin works in treating patients with relapsedor refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer.Biological therapies, such as talactoferrin, may stimulate the immune system in differentways and stop tumor cells from growing

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  • Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

    Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety ofbosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phaseChronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at oneyear.

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  • Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

    This phase I/II trial is studying the side effects and best way to give nilotinib when giventogether with imatinib mesylate after donor stem cell transplant in treating patients withacute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and imatinibmesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cellgrowth.

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  • Dasatinib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate

    This phase I trial is studying the side effects and best dose of dasatinib in treating youngpatients with recurrent or refractory solid tumors or Philadelphia chromosome-positive acutelymphoblastic leukemia or chronic myelogenous leukemia that did not respond to imatinibmesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymesneeded for cell growth

    Investigators

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  • Phase 2 Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia

    The primary objective of this study was to evaluate the safety and efficacy of thecombination of fludarabine and cyclophosphamide in previously untreated CLL patients.Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-daycycles.

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  • Safety of PCI-32765 in Chronic Lymphocytic Leukemia

    The purpose of this study is to establish the safety and efficacy of orally administeredPCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

    Investigator

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  • A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

    The purpose of this study is to evaluate the safety of lenalidomide and to define themaximum tolerated escalation dose level (MTEDL) when administered by a stepwisedose-escalation schedule in subjects with relapsed or refractory B-cell CLL.

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  • Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

    This is a Phase 1 study evaluating the safety of ABT-263 administered in combination witheither FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.

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  • A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

    This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effectof idelalisib in combination with rituximab on the onset, magnitude, and duration of tumorcontrol in participants previously treated for chronic lymphocytic leukemia (CLL). Eligiblepatients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receiveeither idelalisib plus rituximab or placebo plus rituximab. Participants who are toleratingprimary study therapy but experience definitive CLL progression are eligible to receiveactive idelalisib therapy in the extension study, GS-US-312-0117.

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  • Efficacy and Safety of Idelalisib (GS-1101; CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

    This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab onprogression-free survival (PFS) in participants with previously treated chronic lymphocyticleukemia (CLL).

    Investigator

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  • Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

    The purpose of this study is to determine the safety and effectiveness of different doseregimen of lenalidomide in patients with relapsed or refractory chronic lymphocyticleukemia.

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  • Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116

    This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extensionstudy that is a companion study to Study GS-US-312-0116, to evaluate the effect ofidelalisib on the onset, magnitude, and duration of tumor control.

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  • A Study of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

    This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A administeredas a single agent by IV infusion to patients with relapsed or refractory hematologicmalignancies. In Phase Ib, patients will receive DCDS4501A in combination with rituximab.

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  • Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma

    The purpose of this study is to establish the safety and optimal dose of orally administeredPCI-32765 in patients with recurrent B cell lymphoma.

    Investigator

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  • A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

    This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effectof idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients willbe randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisibor placebo. All subjects will be administered bendamustine and rituximab.

    Investigator

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  • Transplantation for Patients With Chronic Lymphocytic Leukemia

    To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic celltransplantation for the treatment of chronic lymphocytic leukemia.

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  • Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies

    The purpose of this study is to determine the dose that can be safely given to see whateffect it may have on your cancer and to determine how the drug is distributed in the body.

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  • Biomarker To Evaluate Protein Profiles of Neutropenic Fever/Infection With Acute or Chronic Leukemias

    The purpose of this study is to measure, in pilot/observational study, panels of circulatingproteins in real time at the onset of neutropenic fever/infection in patients with acute orchronic leukemias undergoing chemotherapy or other biologic treatment. And to generatepreliminary trend results in panels of circulating proteins longitudinally during the periodof neutropenia and to correlate those values to clinical/laboratory data and patientoutcomes.

    Investigator

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  • Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

    The main objective of this study is to learn which sapacitabine treatment is more likely tokeep the cancer in check for at least one year in AML patients who are at least 70 years ofage or older and in MDS patients who are at least 60 years of age.

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  • A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)

    Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for thetreatment of pediatric patients 1 to 21 years old with relapsed acute or refractorylymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

    There is no recommended standard treatment for relapsed or refractory acute myelogenousleukemia in older patients. Cytarabine is the most commonly used drug to treat thesepatients. This study will determine if there is benefit by combining clofarabine withcytarabine. Patients will be randomized to receive up to 3 cycles of treatment with eitherplacebo in combination with cytarabine or clofarabine in combination with cytarabine.Randomization was stratified by remission status following the first induction regimen (noremission [i.e., CR1 = refractory] or remission <6 months vs CR1 = remission ≥6 months). CR1is defined as remission after first pre-study induction regimen. The safety and tolerabilityof clofarabine in combination with cytarabine and cytarabine alone will be monitoredthroughout the study.

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  • Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

    The overall aim of this study is to assess the efficacy and safety of AS1411, over a rangeof doses, when combined with cytarabine, in the treatment of patients with primaryrefractory or relapsed acute myeloid leukemia (AML).

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  • Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia

    Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety andefficacy of distinct temozolomide treatment regimens for patients with AML and poorprognosis

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  • Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

    The purpose of this study is to compare the effectiveness of two multi-agent chemotherapyregimens using different dosages of cytarabine to eliminate all detectable leukemia.

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  • Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia

    This phase II trial is studying the side effects and best dose of bortezomib and to see howwell it works when given together with combination chemotherapy in treating younger patientswith recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stopthe growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugsused in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different waysto stop the growth of cancer cells, either by killing the cells or by stopping them fromdividing. Giving more than one drug (combination chemotherapy) together with bortezomib maykill more cancer cells

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  • Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML

    The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine(Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugsincrease the effect of GO against leukemia cells in the test tube, but we don't know yetwhether they also increase the anti-leukemia effect of GO in people.

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  • Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    The purpose of this study is to compare the effects, good and/or bad, of a standardchemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combinedwith or without midostaurin (also known as PKC412), to find out which is better. Thisresearch is being done because it is unknown whether the addition of midostaurin tochemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has beentested in over 400 patients and is being studied in a number of illnesses, including AML,colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known asFLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cellswill have the abnormal FLT3 gene. This study will focus only on patients with leukemia cellswith the abnormal FLT3 gene.

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  • Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

    This study has a phase 1 and a phase 2 component.

    In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomidewhen after azacitidine.

    In phase 2, the objective is to determine the efficacy of the combination treatment.

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  • Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

    This phase II trial is studying the side effects of giving azacitidine together withgemtuzumab ozogamicin to see how well it works in treating older patients with previouslyuntreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work indifferent ways to stop the growth of cancer cells, either by killing the cells or bystopping them from dividing. Azacitidine may also stop the growth of cancer cells byblocking some of the enzymes needed for cell growth. Monoclonal antibodies, such asgemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability ofcancer cells to grow and spread. Others find cancer cells and help kill them or carrycancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicinmay kill more cancer cells.

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  • Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

    This phase II trial studies how well giving decitabine together with midostaurin works intreating older patients with newly diagnosed acute myeloid leukemia. Decitabine andmidostaurin may stop the growth of cancer cells by blocking some of the enzymes needed forcell growth.

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  • Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

    Time-to-Progression (TTP)

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  • Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

    This Phase II trial is studying how well giving epratuzumab together with an establishedchemotherapy platform works in treating young patients with relapsed acute lymphoblasticleukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in differentways. Some block the ability of cancer cells to grow and spread. Others find cancer cellsand help kill them or carry cancer-killing substances to them. Chemotherapy drugs work indifferent ways to stop the growth of cancer cells, either by killing them or by stoppingthem from dividing. Giving monoclonal antibody therapy in combination chemotherapy may killcancer cells more effectively.

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  • A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

    This study will utilize Erwinaze via intravenous administration in patients between the agesof 1 and 30 who have experienced an allergy to their frontline therapy. The study willdetermine the proportion of patients with 2 day nadir serum asparaginase activity levelsthat are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

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  • Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

    RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, andleucovorin calcium, work in different ways to stop cancer cells from dividing so they stopgrowing or die. Giving more than one drug may kill more cancer cells. It is not yet knownwhich combination chemotherapy regimen is more effective in treating acute lymphoblasticleukemia.

    PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it workscompared to prednisone during induction therapy. This trial is also studying methotrexateand leucovorin calcium to see how well they work compared to methotrexate alone duringmaintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.

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  • Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    This clinical trial is studying risk-group classification of patients with newly diagnosedacute lymphoblastic leukemia. Developing a risk-group classification guide may help doctorsassign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinicaltrials.

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  • T-cell Minimal Residual Disease (MRD) Evaluation Using Flow Cytometric Analysis

    To determine if MRD (minimal residual disease) can be found in the blood (only) as opposedto bone marrow in children with ALL (acute lymphoblastic leukemia).

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  • Phase II Study of VELCADE for Relapsed or Refractory T-cell Prolymphocytic Leukemia

    We hope to learn more about the clinical efficacy of bortezomib in T-cell prolymphocyticleukemia. Patients will be selected as a possible participant in this study because theyhave a bone marrow disorder known as T-cell prolymphocytic leukemia (T-cell PLL) which doesnot tend to respond well to conventional treatment with chemotherapy.

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  • S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

    RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in differentways. Some block the ability of cancer cells to grow and spread. Others find cancer cellsand help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy,such as cytarabine and clofarabine, work in different ways to stop the growth of cancercells, either by killing the cells or by stopping them from dividing. Giving epratuzumabtogether with cytarabine and clofarabine may kill more cancer cells.

    PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumabtogether with cytarabine and clofarabine works in treating patients with relapsed orrefractory acute lymphoblastic leukemia.

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  • Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

    This pilot, phase II trial studies the side effects of giving bortezomib together withcombination chemotherapy and to see how well it works in treating young patients withrelapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop thegrowth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used inchemotherapy work in different ways to stop the growth of cancer cells, either by killingthe cells or by stopping them from dividing. Giving bortezomib together with combinationchemotherapy may kill more cancer cells.

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  • Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

    This clinical trial is looking at brain function in young patients receiving methotrexatefor acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate onbrain function may help doctors plan cancer treatment.

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  • Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

    The Phase 1 portion of this study will assess the safety, tolerability and efficacy atincreasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed orrefractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy ofinotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients insecond or later salvage status.

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  • Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

    This randomized phase III trial is studying low-dose vincristine to see how well it workscompared with high-dose vincristine when given together with different combinationchemotherapy regimens in treating young patients with intermediate-risk relapsed B-cellacute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop thegrowth of cancer cells, either by killing the cells or by stopping them from dividing.Giving more than one drug (combination chemotherapy) and giving the drugs in different waysand different doses may kill more cancer cells..

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  • Study of Denosumab in Subjects With Giant Cell Tumor of Bone

    To determine how safe denosumab is in treating subjects with giant cell tumor of bone

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  • Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumorcells, either by killing the cells or by stopping them from dividing. Giving more than onedrug (combination chemotherapy) may kill more tumor cells.

    PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acidwhen given together with combination chemotherapy in treating patients with newly diagnosedmetastatic osteosarcoma.

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  • Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

    RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with thegrowth of tumor cells and shrink the tumor so that it can be removed during surgery.Sargramostim may then kill any tumor cells remaining after surgery. This may be an effectivetreatment for osteosarcoma that has spread to the lung.

    PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treatingpatients who are undergoing surgery for the first recurrence of osteosarcoma that has spreadto the lung.

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  • Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

    This randomized phase III trial is studying combination chemotherapy followed by surgery andtwo different combination chemotherapy regimens with or without PEG-interferon alfa-2b tocompare how well they work in treating patients with osteosarcoma. Drugs used inchemotherapy work in different ways to stop the growth of tumor cells, either by killing thecells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferonalfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapybefore surgery may shrink the tumor so it can be removed. Giving combination chemotherapytogether with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It isnot yet known whether giving combination therapy together with PEG-interferon alfa-2b ismore effective than two different combination chemotherapy regimens alone after surgery intreating osteosarcoma.

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  • A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer

    The purpose of this Phase II study is to determine if AZD4877, an experimental drug that isa novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes withtumor cell division leading to tumor growth), can reduce tumor sizes in patients withbladder cancer

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  • Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma

    This phase II trial studies how well vismodegib works in treating younger patients withrecurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.

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  • Cyberknife Radiosurgery and Quality of Life

    The purpose of this study is to look at pain control and QOL improvement after treatmentwith CK Radiosurgery for spinal metastases.

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  • Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used inchemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work indifferent ways to stop tumor cells from dividing so they stop growing or die. Givingradiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It isnot yet known whether standard-dose radiation therapy combined with chemotherapy aftersurgery is more effective than reduced-dose craniospinal (head and spine) radiation therapyplus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boostradiation therapy combined with chemotherapy in treating medulloblastoma.

    PURPOSE: This randomized phase III trial is studying standard-dose radiation therapy to seehow well it works compared to reduced-dose craniospinal radiation therapy AND posteriorfossa boost radiation therapy to see how well it works compared to tumor bed boost radiationtherapy when given together with chemotherapy in treating young patients who have undergonesurgery for newly diagnosed standard-risk medulloblastoma.

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  • Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma

    This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab tosee how well they work compared with each other when given together with radiation therapyfollowed by bevacizumab and temozolomide in treating young patients with newly diagnosedhigh-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of theenzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work indifferent ways to stop the growth of tumor cells, either by killing the cells or by stoppingthem from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth indifferent ways. Some block the ability of tumor cells to grow and spread. Others find tumorcells and help kill them or carry tumor-killing substances to them. Radiation therapy useshigh-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat ismore effective then temozolomide or bevacizumab when given together with radiation therapyin treating glioma.

    Investigator

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  • Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma

    This randomized phase III trial studies different chemotherapy and radiation therapyregimens to compare how well they work in treating young patients with newly diagnosed,previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such asvincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways tostop the growth of tumor cells, either by killing the cells, by stopping them from dividing,or by stopping them from spreading. Giving more than one drug (combination chemotherapy) maykill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cellsmore sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells.Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet knownwhich chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

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  • Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis

    The purpose of this study is to determine whether [18F]FHBG is suitable for use as animaging probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapytrials. In this phase 1 study we will assess the safety and biodistribution of [18F]FHBG inpatients.

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  • Cyberknife Precision Radiation Delivery System for Tumors of the Spine

    The purpose of this study is to determine the usefulness of Cyberknife precision radiationin eliminating or preventing the further growth of spinal tumors and lesions.

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  • XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

    The purpose of this study is to examine the safety and efficacy of XERECEPT (humanCorticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primarymalignant glioma who require increased dexamethasone doses to control symptom of peritumoralbrain edema.

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  • An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

    The purpose of this study is to examine the long-term safety and tolerability of humancorticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone(Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open toall patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or otherdesignated studies, including patients who may have discontinued blinded study medicationearly but completed the protocol-stipulated follow-up periods.

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  • Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

    RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly tothe tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used inchemotherapy use different ways to stop tumor cells from dividing so they stop growing ordie. Giving chemotherapy before surgery may shrink the tumor so that it can be removedduring surgery.

    PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapyeither alone or after chemotherapy and second surgery in treating children who haveundergone surgery for localized ependymoma.

    Investigator

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  • Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors

    RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells fromdividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrinkthe tumor so that it is no longer present by conventional imaging and tumor markers fromserum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumorcells. Peripheral stem cell transplantation may allow the doctor to give higher doses ofchemotherapy drugs and kill more tumor cells. Combining different types of therapy may killmore tumor cells.

    PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or withoutsurgery and with or without high dose chemotherapy and peripheral stem cell transplantation,can increase response rates prior to radiation therapy and increase progression free andoverall surviving patients with newly diagnosed intracranial germ cell tumors.

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  • Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma

    RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop thegrowth of tumor cells, either by killing the cells or by stopping them from dividing.Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found inbone marrow or peripheral blood and may help the immune system recover from the side effectsof chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecanmay make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSFtogether with radiation therapy may be an effective treatment for brain stem glioma.

    PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan whengiven together with G-CSF and radiation therapy and to see how well they work in treatingyoung patients with newly diagnosed brain stem glioma.

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  • Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

    RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells fromdividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damagetumor cells. Giving more than one chemotherapy drug with radiation therapy may kill moretumor cells.

    PURPOSE: This phase II trial is studying how well giving intrathecal and systemiccombination chemotherapy together with radiation therapy works in treating young patientswith newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.

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  • XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

    The purpose of this study is to compare the safety and efficacy of XERECEPT® todexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). Thisstudy is specifically aimed at patients who require chronic high doses of dexamethasone tomanage symptoms.

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  • Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma

    To investigate the safety of delivering arsenic trioxide (ATO) in combination withstereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase Idose escalation trial. Results from this study will provide a basis for further study of ATOcombined with radiation therapy as a radiosensitizer for malignant brain tumors in futurePhase II studies.

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  • Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

    This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oraletoposide in patients with recurrent or refractory pediatric ependymoma.

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  • Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

    Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205and either progressed while on study or discontinued due to unacceptable toxicity related toetoposide were allowed to participate in this study to assess the safety profile ofsingle-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.

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  • Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

    RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in differentways. Some find cancer cells and kill them or carry cancer-killing substances to them.Others interfere with the ability of cancer cells to grow and spread. Drugs used inchemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone,and cytarabine, work in different ways to stop the growth of cancer cells, either by killingthe cells or by stopping them from dividing. Giving rituximab together with combinationchemotherapy may kill more cancer cells.

    PURPOSE: This phase II trial is studying how well giving rituximab together with combinationchemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.

    Investigator

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  • Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing

    To implement a new method of performing chest CT imaging in young children at PackardChildren's Hospital entitled controlled ventilation infant/young child chest CT scanning.This technique will be used to evaluate early lung disease comparing quantitative chest CTair trapping and airway measurements with lung function measurements in infants, toddlers,and young children with chronic lung disease.

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  • Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase III trial is studying the side effects and how well giving dasatinib togetherwith combination chemotherapy works in treating young patients with newly diagnosed acutelymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking someof the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways tostop the growth of cancer cells, either by killing the cells or by stopping them fromdividing. Giving dasatinib together with combination chemotherapy may kill more cancercells.

    Investigator

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  • Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

    Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia.Nilotinib works by blocking the action of a protein that might be important for the growthof pigmented villonodular synovitis (PVNS). In this research study the investigators aretesting whether nilotinib can stop the growth of PVNS or improve the symptoms experiencedfrom PVNS.

    Investigator

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  • High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used inchemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth oftumor cells, either by killing the cells or by stopping them from dividing. Monoclonalantibodies, such as cetuximab can block tumor growth in different ways. Some block theability of tumor cells to grow and spread. Others find tumor cells and help kill them orcarry tumor-killing substances to them. It is not yet known whether high-dose radiationtherapy is more effective than standard-dose radiation therapy when given together withcombination chemotherapy with or without cetuximab in treating patients with non-small celllung cancer.

    PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiationtherapy given together with chemotherapy with or without cetuximab to see how well they workin treating patients with newly diagnosed stage III non-small cell lung cancer that cannotbe removed by surgery.

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  • Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specializedradiation therapy that delivers a high dose of radiation directly to the tumor may kill moretumor cells and cause less damage to normal tissue. It is not yet known which regimen ofstereotactic body radiation therapy is more effective in treating patients with non-smallcell lung cancer.

    PURPOSE: This randomized phase II trial is studying the side effects of two radiationtherapy regimens and to see how well they work in treating patients with stage I non-smallcell lung cancer.

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  • Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell)

    Open-label, phase 2, single-arm, multi-center study of bevacizumab in combination withgemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lungcancer (NSCLC).

    Investigator

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  • High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma

    RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide,etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stopthe growth of tumor cells, either by killing the cells or by stopping them from dividing.Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combinationchemotherapy together with radiation therapy may kill more tumor cells.

    PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapytogether with radiation therapy works in treating patients with newly diagnosed metastaticrhabdomyosarcoma or ectomesenchymoma.

    Investigator

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  • Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis

    RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly tothe tumor may kill more tumor cells and cause less damage to normal tissue.

    PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgeryor stereotactic body radiation therapy works and compares it to external-beam radiationtherapy in treating patients with localized spine metastasis. (phase II completed as of8-30-11)

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  • Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

    This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography(PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnosticprocedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bonecancer

    Investigator

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  • Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer

    RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused bychemotherapy and radiation therapy. It is not yet known whether Manuka honey is moreeffective than standard care in preventing pain.

    PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well itworks in preventing esophagitis-related pain in patients receiving chemotherapy andradiation therapy for lung cancer.

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  • Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

    This randomized phase III trial studies chemotherapy and bevacizumab to see how well theywork compared to chemotherapy alone in treating patients with stage IB, stage II, or stageIIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy workin different ways to stop the growth of tumor cells, either by killing the cells, bystopping them from dividing, or by stopping them from spreading. Giving more than one drug(combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such asbevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumabalso may stop the growth of non-small cell lung cancer by blocking the growth of new bloodvessels necessary for tumor growth. It is not yet known whether chemotherapy is moreeffective with or without bevacizumab in treating non-small cell lung cancer.

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  • Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    This randomized phase III trial is studying different combination chemotherapy regimens andcomparing how well they work in treating patients with newly diagnosed acute lymphoblasticleukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancercells, either by killing the cells or by stopping them from dividing. Giving more than onedrug (combination chemotherapy) may kill more cancer cells.

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  • Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies

    The purpose of the study is to conduct a phase I study of adoptive immunotherapy withautologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse ratein autologous stem cell transplant patients with high-risk hematologic malignancies.

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  • Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

    This randomized clinical trial is studying giving calaspargase pegol together withcombination chemotherapy to see how well it works compared with giving pegaspargase togetherwith combination chemotherapy in treating younger patients with newly diagnosed high-riskacute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop thegrowth of cancer cells, either by killing the cells or by stopping them from dividing.Giving more than one drug (combination chemotherapy) may kill more cancer cells.

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  • National Lymphatic Disease and Lymphedema Registry

    The purpose of the National Lymphatic Disease and Lymphedema Registry is to collect healthinformation in order to study the disease classification, natural history, and impact ofLymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.

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  • Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

    RATIONALE: Surgery with or without internal radiation therapy may be an effective treatmentfor non-small cell lung cancer. Internal radiation uses radioactive material placed directlyinto or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able tosend x-rays directly to the tumor and cause less damage to normal tissue. It is not yetknown whether stereotactic body radiation therapy is more effective than surgery with orwithout internal radiation therapy in treating non-small cell lung cancer.

    PURPOSE: This randomized phase III trial is studying how well surgery with or withoutinternal radiation therapy works compared with stereotactic body radiation therapy intreating patients with high-risk stage IA or stage IB non-small cell lung cancer.

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  • Erwinase Master Treatment Protocol

    The purpose of this study is to make Erwinase available to patients with acute lymphoblasticleukemia (ALL) who have had previous allergic reactions to certain formulations ofL-asparaginase.

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  • Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia

    This clinical trial is studying the side effects of Erwinia asparaginase and what happens tothe drug in the body in treating young patients with acute lymphoblastic leukemia who areallergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, workin different ways to stop the growth of cancer cells, either by killing the cells or bystopping them from dividing.

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  • Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients

    This is a multi-center trial for rasburicase in children at high risk of tumor lysissyndrome who have a history of asthma/atopy. The main purpose of this study is to establishthe safety of this drug in patients with a history of asthma or severe allergies.

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  • Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

    BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for theirgrowth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treatingpatients who have recurrent or refractory advanced T-cell leukemia.

    Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated everyweek for up to six courses. Patients are not required to be hospitalized for theadministration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777twice a week for 6 weeks.

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  • Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

    RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells fromdividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damagecancer cells. Giving combination chemotherapy together with radiation therapy may kill morecancer cells.

    PURPOSE: This clinical trial is studying how well giving chemotherapy together withradiation therapy works in treating patients with acute lymphoblastic leukemia that hasrelapsed in the CNS and/or testes.

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  • Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

    Evaluate the role of high dose chemotherapy with autologous hematopoietic celltransplantation for AML.

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  • Allo BMT in Advanced Leukemia or High Grade Lymphoma

    To evaluate the role of ablative allogeneic hematopoietic cell transplantation in thetreatment of advanced leukemia or lymphoma.

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  • A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

    The purpose of the study is to determine whether the combination of aflibercept, pemetrexedand cisplatin is safe and effective.

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  • Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer

    This study has two primary objectives. The first objective is to determine the maximaltolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients withinoperable malignant lung tumors. Once the MTD is established, the second objective is todetermine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms andradiographic responses.

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  • A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

    This open-label trial will evaluate a dose of oral lenalidomide 10 mg taken daily on days1-21 of 28 day cycle. Oral melphalan 0.18mg/kg will be taken on days 1-4 of a 28 day cycle.Oral dexamethasone 40 mg will be taken on days 1, 8, 15 and 22 of a 28 day cycle. Up to 15patients over the age of 18 with newly diagnosed or relapsed AL amyloidosis will be includedin this study. In the absence of disease progression or toxicity, patients will completenine cycles of therapy. After nine cycles, subjects have the option of continuinglenalidomide therapy alone. The primary objective of this study is safety and tolerabilityof the above regimen. The secondary objectives are hematologic and organ responses, as wellas time to progression.

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  • First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

    The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), incombination with gemcitabine in patients with Transitional Cell Carcinoma who cannot betreated with cisplatin. This study will help to determine whether vinflunine in combinationwith gemcitabine will extend the time period until further growth of the tumor more thangemcitabine alone.

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  • Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

    RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in theurine may improve the ability to detect bladder cancer without invasive procedures.

    PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sedimentin the urine in detecting bladder cancer in healthy participants, participants who havegenitourinary conditions requiring cystoscopy, and patients who have bladder cancer.

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  • Identification of Serum Markers For Tumor Hypoxia in Non-Small Cell Lung Cancers

    The purpose of the study is to identify a surrogate serum marker for tumor hypoxia inpatients with lung cancers.

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