Education and Training

  • COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol

    The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients.

    COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.

    Not accepting patients at this time View Details
  • Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer

    This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.

    Not accepting patients at this time View Details
  • Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.

    The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone marrow Transplantation are enrolling patients into a research study to determine if donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.

    Now accepting new patients View Details
  • Brief Behavioral Intervention for Insomnia During Chemotherapy

    PRIMARY OBJECTIVE(S):

    To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.

    SECONDARY OBJECTIVE(S):

    - To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.

    - To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators

    Not accepting patients at this time View Details
  • Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy

    This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.

    Investigator

    Not accepting patients at this time View Details
  • Addressing Diabetes by Elevating Access to Nutrition

    The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes.

    Specifically, ADELANTE aims to

    1. determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months,

    2. examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and

    3. assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.

    Investigator

    Now accepting new patients View Details
  • A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

    This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204; PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is <100 patients.

    Not accepting patients at this time View Details
  • A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma

    This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.

    Investigator

    Not accepting patients at this time View Details
  • Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia

    The objectives of this study are to assess the safety of azficel-T treatment for dysphonia related to vocal fold function and to evaluate the efficacy of azficel-T for the treatment of dysphonia related to vocal fold function.

    Not accepting patients at this time View Details
  • A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

    This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

    Not accepting patients at this time View Details
  • Bromocriptine for Patients With Schizophrenia and Prediabetes

    This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures include body weight, fasting lipids, and prolactin. The specific aims are as follows: Specific aim 1: To establish the safety and tolerability of bromocriptine in patients with schizophrenia and IGT/IR treated with APDs. Specific aim 2: To demonstrate feasibility/proof of concept for an improvement in APD-induced IGT/IR with bromocriptine.

    Investigator

    Not accepting patients at this time View Details
  • A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups

    PanFAM-1 is a clinical study for early detection of pancreatic cancer in high-risk groups. The goals of the study are to assess the performance and diagnostic accuracy of the IMMray™ PanCan-d test compared to standard-of-care imaging.

    Not accepting patients at this time View Details
  • Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    This randomized phase III trial studies chemotherapy to see how well it works with or without bevacizumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck squamous cell carcinoma.

    Not accepting patients at this time View Details
  • A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

    This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

    Not accepting patients at this time View Details
  • 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 maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.

    Not accepting patients at this time View Details
  • A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors

    A phase 1 open-label dose escalation study of OMP-21M18 in subjects with previously treated solid tumour for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit.

    Not accepting patients at this time View Details
  • Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

    The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

    Investigator

    Now accepting new patients View Details
  • Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4

    Primary Objectives

    - Determine the biodistribution of [18F]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives

    - Determine the dosimetry of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.

    - Determine the acute toxicity of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.

    - Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy.

    - Determine/verify the safety profile of the [18F]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer.

    - Determine the time of maximal [18F]-C-SNAT4 radiotracer uptake post injection.

    Now accepting new patients View Details
  • Biomarkers for the Detection of Lymphatic Insufficiency

    Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is frequently under-recognized or misdiagnosed. This study is designed to lead to the development of an accurate, noninvasive, blood test to allow testing for lymphedema. This approach is particularly useful to investigate relative responses to treatment interventions.

    Investigator

    Now accepting new patients View Details
  • An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

    This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to provide atezolizumab access to participants with locally advanced or metastatic urothelial carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy regimen.

    Investigator

    Not accepting patients at this time View Details