Clinical Trial Alliance 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)
- Principal Investigator
- Orin Bloch
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.Alliance A071101
- The purpose of this study is to compare what effects, good and/or bad, a vaccine called HSPPC-96 given with a drug called bevacizumab versus bevacizumab alone has on recurrent glioblastoma multiforme (GBM).
- HSPPC-96 is experimental (not approved by the U.S. Food and Drug Administration [FDA]). HSPPC-96 is a protein made from the tissue of the GBM and then given back in the form of a vaccine. Earlier studies showed significant immune response (improvement in the body's ability to fight disease) and it is hoped that this will target an attack against the remaining brain tumor cells. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels and is used as treatment recurrent (cancer that has come back) glioblastoma. The use of HSPPC-96 in combination with bevacizumab is investigational.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have diagnosis of recurrent GBM (it has returned after prior treatment).
- Participants GBM must be considered surgically resectable (able to be removed by surgery).
- Participants must not have had prior treatment with any anti-angiogenic agent (drug) targeting the vascular endothelial growth factor (VEGF), for example bevacizumab. Contact the study doctor for questions regarding these drugs.
- Description of Treatment
- Participants will be randomized (like the flip of a coin) into one of three groups known as Arms. Arm 1 participants will receive the HSPPC-96 vaccine about 4 weeks after surgery. The vaccine is given as an injection into the skin (a shot). Participants will get the vaccine once a week for 4 weeks (4 shots), then every other week for 6-12 more doses. During this same time, participants will get bevacizumab every 2 weeks. Bevacizumab is given intravenously (through a vein in the arm; IV). In Arm 2, about 4 weeks after surgery, participants will receive the HSPPC-96 vaccine alone. They will then get bevacizumab if the tumor comes back. In Arm 3, about 4 weeks after surgery, participants will receive bevacizumab alone. Participants will continue to get HSPCC-96 and/or bevacizumab until the tumor comes back or the study doctor decides it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 09-Dec-16 07:37 AM
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