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Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery


Title A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)
Therapeutic Area Brain Tumors
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender Both
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT01814813

Overview

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone. HSPPC-96 is experimental and is made from tissue taken from the brain tumor. Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells. Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone. The use of HSPPC-96 in combination with bevacizumab is also investigational

Study Details

Inclusion Criteria

  • First or second recurrence of glioblastoma multiform (GBM) that can be removed using surgery
  • Otherwise normal organ function

Exclusion Criteria

  • No pregnant or nursing women
  • No prior treatment with bevacizumab or HSPPC-96
  • No complicating malignancies such as uncontrolled cardiovascular disease or bleeding disorder

Study Requirements

Subjects will come to the hospital once a week for vaccine injections and/or every 2 weeks for bevacizumab infusions. Subjects will have an MRI every 8 weeks.