Education and Training

  • Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

    To determine whether using a radiolabelled analog of 5-FU, [18F]-5-fluorouracil, for PET/CT imaging can visually demonstrate differential chemotherapy delivery to known tumor sites before and after administration of bevacizumab and determine the optimal timing of bevacizumab administration to maximize the chemotherapy delivery into the tumor for improved cancer treatment.

    Investigator

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  • Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma

    This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.

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  • Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

    The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

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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 monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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  • Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

    To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

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  • A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors

    In this study, patients with advanced solid tumors will undergo [18F]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.

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  • Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

    Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

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  • A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

    Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).

    Investigator

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  • A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

    The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.

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  • Axicabtagene Ciloleucel Expanded Access Study

    A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma.

    Subjects who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

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  • Bronchitis and Emphysema Advice and Training to Reduce Hospitalization

    EXECUTIVE SUMMARY:

    Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD.

    Hypotheses:

    Primary Hypothesis:

    Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care.

    Primary Objective:

    In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care.

    Secondary Hypotheses:

    Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy.

    Secondary Objectives:

    To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by:

    A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures

    1. Mortality

    2. Health-related quality of life measured by generic and COPD-specific measures

    3. Patient satisfaction

    4. Medication adherence

    5. Disease knowledge, skill acquisition and self-efficacy

    In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.

    The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.

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  • Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

    This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

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  • BIBW 2992 (Afatinib) in Head & Neck Cancer

    The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.

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  • A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer

    Objectives

    - Primary: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib

    - Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib

    Investigator

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  • Antihypertensive Treatment of Acute Cerebral Hemorrhage-II

    The specific aims of this study are to:

    1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.

    2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.

    3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans.

    4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.

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  • Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer

    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

    PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.

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  • A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer

    The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Secondary goals are to describe the safety and tolerability at this dose and schedule, to determine the time to sustained biochemical response, to determine the duration of biochemical response, to determine the time to disease progression.

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  • A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

    This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

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  • A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)

    This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy compared with chemotherapy alone in subjects with previously treated metastatic breast cancer.

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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 with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

    Investigators

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