Brain Tumor Clinical Trials
City of Hope currently has many clinical trials in progress, a number of which address malignant brain tumors. Clinical trials offer patients new and promising experimental treatments not available elsewhere. In fact, nearly one in two patients at City of Hope is part of a clinical trial. These trials evaluate the safety and efficacy of prospective therapies. Participants in clinical trials receive excellent care and are closely monitored. We encourage all brain tumor patients to participate in clinical trials since that will enable us to find better treatments for brain tumors.
 
 
For more information about the studies listed below including eligibility criteria, please call: 626-471-9393. For a summary of these studies including eligibility criteria, visit the City of Hope clinical trials website.
 
Newly Diagnosed
 
11216 
A Phase III clinical trial using a vaccine targeting EGF
An International, Randomized, Double-Blind, Controlled Study of Rindopepinut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The "ACT IV" Study)

Rindopepinut is a vaccine targeted against EGFRvIII gene, which is active in approximately 30% of glioblastoma patients. It is designed to target tumor cells that remain after surgery and chemoradiation.

Patients who are interested in enrolling in this clinical trial need to meet specific eligibility requirements, which include:
 
  • Brain Tumor must test positive for EGFRvIII
  • Participants will be randomized to receive either  vaccine or placebo
 
 
 
11180  
A Phase III Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma
 
13126  
A prospective, Multi-Center Trial of Novo TFF-100A together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed Gioblastoma
 
 
Recurrent Disease

13116
A Phase I Gene Therapy Trial of the Safety and Tolerability of Toca 511 in patients Recurrent High Grade Glioma
 
LEARN MORE ABOUT THE TOCA 511 & TOCA FC STUDIES
TOCA 511 & TOCA FC mechanism
This is a very exciting new experimental gene therapy treatment for high grade brain tumors. The basic concept is that a virus (Toca 511) is injected into the tumor. This virus was designed to infect only the brain tumor cells and leave the normal cells alone. When it infects a cell, it adds a gene to the cell which encodes for an enzyme that can convert an antibiotic drug (Toca FC) into a toxic chemotherapy (5-FU), selectively in the tumor. This drug (Toca FC) is given orally every few weeks, and it kills the tumor cells that have enough copies of this enzyme to convert Toca FC to 5-FU. The tumor cells that are infected but don't have enough of the enzyme act as a reservoir - they start the process over again - spreading the infection for a few more weeks, and these cycles are repeated over and over again until the entire tumor is potentially gone.
 
If you were diagnosed with Recurrent High Grade Glioma (HGG) (glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma and anaplastic oligoastrocytoma) that have increased in size following treatment with surgery, radiation therapy and temozolomide. The Toca 511 and Toca FC studies might be the studies for you.
 
Who can participate in the Toca 511 & Toca FC studies? You may qualify for a Toca 511 & Toca FC study if you:
 
  • Are at least 18 years old (upper limit of 80 years in one of the studies)
  • Have recurrent HGG
     
Your doctor will be able to review with you these and other eligibility criteria. For more information about the Toca 511 & Toca FC studies, please contact Jana Portnow M.D. or Behnam Badie M.D. at  626-471-9393 or visit www.tocagen.com.