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 2 Study to Evaluate the clinical Efficacy and Safety of MEDI4736 in Patients with Glioblastoma
Description: A multi-center phase II study testing MEDI4736 with 3 arms for different patient populations. Cohort A combines MEDI4736 with radiation in patients with newly-diagnosed, MGMT-unmethylated glioblastoma. Cohort B treats patients with recurrent, bevacizumab-naive glioblastoma with MEDI4736 alone, Cohorts B2 and B3 treat pattients with recurrent, bevacizumab-naive glioblastoma with both MEDI4736 and bevacizumab, and Cohort C treats patients with recurrent, bevacizumab-refractory glioblastoma with both MEDI4736 and bevacizumab. Cohort A is the only cohort still enrolling patients; all the other cohorts have been filled.
Link: https://www.clinicaltrials.gov/ct2/show/NCT02336165
PI: Jennifer Clarke
Clinic contact: 415-353-2966

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: https://clinicaltrials.gov/ct2/show/NCT02311920
PI: Nicholas Butowski
Clinic contact: 415-353-2966



Recurrent Glioblastoma


Title: A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the treatment of Surgically Resectable Recurrent Glioblastoma.
Description: A multi-center, cooperative group trial on which patients undergo surgical resection of recurrent glioblastoma, from which an autologous vaccine is made. If resection and vaccine synthesis are successful, patients are randomized to vaccine with concurrent bevacizumab, vaccine alone followed by bevacizumab at second progression, or bevacizumab alone.
Link: https://www.clinicaltrials.gov/ct2/show/NCT01814813
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: https://clinicaltrials.gov/ct2/show/NCT02022644
PI: Nicholas Butowski
Clinic contact: 415-353-2966


(Pending) 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


(Pending) 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


(Pending) Title: A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma
Description: This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or anaplastic astrocytoma. Patients will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Due to the prognostic influence of molecular subgroups such as isocitrate dehydrogenase mutation, the trial will be stratified based on this determination from the primary pathology or subsequent biopsy known locally or otherwise determined centrally. A second stratification factor is based on the patient's Karnofsky Performance Score (70-80 vs 90-100). The study will be conducted in 2 parts; enrollment in the phase 3 will begin after phase 2 results are available.
Link: NCT02414165
Clinic contact: 415-353-2966

(Pending) 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: https://clinicaltrials.gov/ct2/show/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: https://clinicaltrials.gov/ct2/show/NCT02796261?term=NCT02796261&rank=1
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: https://www.clinicaltrials.gov/ct2/show/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: https://clinicaltrials.gov/ct2/show/NCT02549833
PI: Hideho Okada
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

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