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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)
Primary Objective:
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 GBM.
Secondary Objectives:
To evaluate the safety and tolerability of HSPPC-96 with bevacizumab.
To evaluate the progression free survival of HSPPC-96 with bevacizumab, given concomitantly or at the point of progression.
Correlative Science Objectives:
To evaluate whether patients who demonstrate an immune response to HSPPC-96 will have an improved survival outcome in comparison to those patients who do not show immune response.
To explore the expression of B7-H1 protein expression and PI3K pathway activation (which are associated with immunoresistance) at the tissue level before treatment and correlate with therapeutic response.
To explore whether T-cell infiltrate of tumor at baseline correlates with response to vaccine.
Primary Objective:
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 GBM.
Secondary Objectives:
To evaluate the safety and tolerability of HSPPC-96 with bevacizumab.
To evaluate the progression free survival of HSPPC-96 with bevacizumab, given concomitantly or at the point of progression.
Correlative Science Objectives:
To evaluate whether patients who demonstrate an immune response to HSPPC-96 will have an improved survival outcome in comparison to those patients who do not show immune response.
To explore the expression of B7-H1 protein expression and PI3K pathway activation (which are associated with immunoresistance) at the tissue level before treatment and correlate with therapeutic response.
To explore whether T-cell infiltrate of tumor at baseline correlates with response to vaccine.
Recruitment Status
Past Studies