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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 th

Brief Summary: This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.

Detailed Summary:

The purpose of this study is to compare the effects of a vaccine with bevacizumab versus bevacizumab alone on a patient's brain tumor. The vaccine is called heat shock protein peptide complex 96 (HSPPC-96). HSPPC-96 is experimental. Specifically, HSPPC-96 is a protein that may work to help the body have a response against remaining brain tumor cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, patients will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if the tumor comes back, or bevacizumab alone. The use of HSPPC-96 and bevacizumab is investigational.

The primary objective of the study is to determine whether there is an overall survival advantage of HSPPC-96 administered with bevacizumab, given concomitantly or at the point of progression, in comparison with bevacizumab alone in patients with surgically resectable recurrent glioblastoma multiforme.

The secondary objectives are:

  1. to evaluate the safety and tolerability of HSPPC-96 with bevacizumab
  2. to evaluate the progression free survival of HSPPC-96 with bevacizumab, given concomitantly or at the point of progression.

Patients must undergo surgery within 28 days from pre-registration. There must be confirmation of adequacy of tissue for vaccine manufacture, tumor tissue submitted to Agenus, confirmation of ≥ 90% resection by central radiology review and vaccine manufacture of at least six vials. Patients will be randomized to one of three treatment arms. Please see the "Arms" section for more details.

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Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome: Overall survival (OS) [ Time Frame: Up to 5 years post-surgery ]

Original Primary Outcome: Overall survival (OS) [ Time Frame: Date from study registration to the date of death, due to any cause, assessed up to 3 years ]

Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years post-surgery ]
  • Treatment related adverse events graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 3 years ]


Original Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: Date from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first), assessed up to 3 years ]
  • Objective tumor response determined using Revised Assessment in Neuro-Oncology (RANO) criteria [ Time Frame: Up to 3 years ]
  • Treatment related adverse events graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 3 years ]


Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: March 18, 2013
Date Started: May 2013
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017