Adult Brain Tumor Clinical Trials

Questions about patients' participation in the following clinical trials can be directed to (415) 353-2966.
Online Appointment Request Form for Patients with Brain Tumors

Search by diagnosis:

Newly Diagnosed Glioblastoma 
Recurrent Glioblastoma 
Grade III Glioma
Low-Grade Glioma, Newly Diagnosed
Low-Grade Glioma, Recurrent
Meningioma


Newly Diagnosed Glioblastoma


Title: Phase I Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
Description: This phase I trial studies the safety and best dose of ipilimumab, nivolumab, or both in combination with temozolomide in treating patients with newly diagnosed glioblastoma. Ipilimumab and nivolumab, may block tumor growth in different ways the ways a tumor may hide from detection by the immune system.
Link: NCT02311920
PI: Nicholas Butowski
Clinic contact: 415-353-2966


Title
: Phase I Two Part Dose Escalation Trial of RRx-001 + Radiation + Temozolomide and RRx-001 + Temozolomide Post-RT in Newly Diagnosed and Anaplastic Gliomas (G-FORCE-1)
Description: This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By "add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or "added on" to standard of care. In newly diagnosed GBM standard of care consists of radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by maintenance TMZ given until the tumor progresses or worsens. By "maintenance" therapy what is meant is that TMZ is given less frequently to prolong or extend the time during which the tumor remains stable. RRx-001 is a radiosensitizer and a chemosensitizer, which means that experimentally it increases the activity of radiation and chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have experienced minimal toxicity or side effects with RRx-001 alone and also in combination with radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well with radiotherapy and TMZ in GBM without adding toxicity.
Link: NCT02871843
PI: Nicholas Butowski
Clinic contact: 415-353-2966


Title
: An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate548)
Link: NCT02667587
PI: Jennie Taylor
Clinic contact: 415-353-2966 


Title
: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Description: This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
Link: NCT02573324
PI: Nicholas Butowski
Clinic contact: 415-353-2966



Recurrent Glioblastoma


Title:  A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma
Description: PD-1 works to help tumor cells continue to grow and multiply. Pembrolizumab (MK-3475) is a humanized monoclonal antibody. Humanized monoclonal is an antibody that is designed to block the action of the receptor, PD-1.
Link: NCT02852655
PI: Jennifer Clarke
Clinic contact: 415-353-2966

Title: Study of Convection-Enhance Delivery, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma
Description: This is a dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery with real time imaging.
Link: NCT02022644
PI: Nicholas Butowski
Clinic contact: 415-353-2966


Title: A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers
Description: This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers, including malignant glioma.
Link: NCT02526017
Clinic contact: 415-353-2966


Title: Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma
Description: This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with recurrent glioblastoma. Tesevatinib is a tyrosine kinase inhibitor that inhibits the function of epidermal growth factor receptor (EGFR), a cell surface receptor found on brain tumor cells.
Link: NCT02844439
Clinic contact: 415-353-2966


Title: Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Glioblastoma at First Recurrence or Progression
Description: This is a single-arm, open-label, multicenter study in approximately 43 adults with primary (de novo) Glioblastoma that has recurred or progressed after failure of first-line therapy [according to Response Assessment in Neuro-Oncology (RANO) criteria]. Eligible patients will receive intratumoral infusion of MDNA55 administered via convection-enhanced delivery (CED).
Link: NCT02858895
PI: Jennifer Clarke
Clinic contact: 415-353-2966

Grade III Glioma


Title: Study of Convection-Enhance Delivery, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma
Description: This is a dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery with real time imaging.
Link: NCT02022644
PI: Nicholas Butowski
Clinic contact: 415-353-2966

Title: Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)
Description: The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
Link: NCT02796261 
PI: Jennifer Clarke
Clinic contact: 415-353-2966



Low-Grade Glioma, Newly Diagnosed


Title: PI3K/mTOR Pathway Activation Selected Phase II Study of Everolimus (RAD001) with and without Temozolomide in the Treatment of Adult Patients with Supratentorial Low-Grade Glioma
Description: Single-institution phase II study testing everolimus in patients with newly-diagnosed low-grade glioma, utilizing molecular characterization to assign patients to treatment with everolimus alone or with combined everolimus/temozolomide.
Link: NCT02023905
PI: Jennifer Clarke
Clinic contact: 415-353-2966

Title: Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
Description: This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Primary objectives are to determine: 1) the safety and feasibility of the neoajduvant approach and 2) whether the regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected glioma.
Link: NCT02549833
PI: Hideho Okada
Clinic contact: 415-353-2966

Title: Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Description: This pilot trial of this iPad-based intervention in glioma patients at University of California, San Francisco (UCSF) will establish feasibility and preliminary efficacy data to support a funding application for a larger clinical trial. Twenty patients with stable low-grade gliomas will complete a computerized battery of standardized neurocognitive tests and quality of life assessments at baseline. Subjects will complete the intervention at home over 3 months. Neuro-cognitive testing will be repeated 3 and 9 months after baseline. Subjects will also complete a post-intervention questionnaire on the usefulness, attractiveness, difficulty and burden of the intervention. Clinical data will be collected at the time of each assessment. This will include diagnostic and treatment history, magnetic resonance imaging (MRI data), tumor genomics and immunohistochemistry.
Link: NCT02783495
PI: Jennie Taylor
Clinic contact: 415-353-2966

Low-grade Glioma, Recurrent


Title: Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation
Description: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced solid tumors, including gliomas, that harbor an IDH1and/or IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-881 to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. The anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or the patient is removed at the discretion of the investigator.
Link: NCT02481154
PI: Jennifer Clarke
Clinic contact: 415-353-2966

Title: Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients Description: This pilot trial of this iPad-based intervention in glioma patients at University of California, San Francisco (UCSF) will establish feasibility and preliminary efficacy data to support a funding application for a larger clinical trial. Twenty patients with stable low-grade gliomas will complete a computerized battery of standardized neurocognitive tests and quality of life assessments at baseline. Subjects will complete the intervention at home over 3 months. Neuro-cognitive testing will be repeated 3 and 9 months after baseline. Subjects will also complete a post-intervention questionnaire on the usefulness, attractiveness, difficulty and burden of the intervention. Clinical data will be collected at the time of each assessment. This will include diagnostic and treatment history, magnetic resonance imaging (MRI data), tumor genomics and immunohistochemistry.
Link: NCT02783495
PI: Jennie Taylor
Clinic contact: 415-353-2966

Meningioma


Title: A Study Looking at Targeted Therapy According to Tumor Markers for People With Meningiomas
Description: This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Link: NCT02523014
PI: Jennie Taylor
Clinic contact: 415-353-2966