GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma
RATIONALE: Vaccines made from a person's tumor cells, such as gp96 heat shock protein-peptide complex, may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gp96 heat shock protein-peptide complex vaccine and to see how well it works in treating patients with recurrent or progressive high-grade glioma.
Brain and Central Nervous System Tumors
Procedure: conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma|
- Safety and maximum tolerated dose [ Time Frame: survival ]
- Frequency of gp96 heat shock protein-peptide complex vaccine (Phase I [closed to accrual as of 7/25/2007]) [ Time Frame: survival ]
- Toxicity (Phase I [closed to accrual as of 7/25/2007]) [ Time Frame: survival ]
- Progression-free survival at 6 months (Phase II) [ Time Frame: 6 months ]
- Immunological response (Phase I [closed to accrual as of 7/25/2007]) [ Time Frame: last vaccine ]
- Safety (Phase II) [ Time Frame: survival ]
- Tumor response as measured by neuro-imaging and neurologic exam (Phase II) [ Time Frame: survival ]
- Survival (Phase II) [ Time Frame: survival ]
- Immunological response (Phase II) [ Time Frame: survival ]
|Study Start Date:||October 2005|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Vaccine with Chemotherapy
Single-arm,(HSPPC-96) administered in combination with temozolomide following standard treatment with radiation and temozolomide.
25 mcg ID
Other Name: Heat ShockProcedure: conventional surgery
- Determine the safety and best tolerated dose and frequency of gp96 heat shock protein-peptide complex vaccine in patients with recurrent or progressive high-grade glioma. (phase I [closed to accrual as of 7/25/2007])
- Determine the clinical response to treatment, time to disease recurrence and progression, and overall survival of patients treated with this vaccine. (phase II)
- Determine the immune response in patients treated with this vaccine.
OUTLINE: This is a dose-escalation, phase I study (closed to accrual as of 7/25/2007) followed by a phase II study.
- Phase I (closed to accrual as of 7/25/2007): Patients undergo surgical resection. Viable tumor tissue is used to generate the gp96 heat shock protein-peptide complex (HSPPC-96) vaccine. Patients with primary disease receive standard adjuvant therapy after surgery. Patients whose disease progresses during or after standard adjuvant therapy receive the HSPPC-96 vaccine. Patients with recurrent disease receive the HSPPC-96 vaccine between 2-8 weeks after surgery. The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for 4 doses and then every 2-3 weeks thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion.
Cohorts of 6 patients receive the HSPPC-96 vaccine at escalating dose frequencies until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive the HSPPC-96 vaccine as in phase I at the appropriate dose frequency determined in phase I (closed to accrual as of 7/25/2007).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293423
|United States, California|
|UCSF Department of Neurosurgery|
|San Francisco, California, United States, 94143|
|United States, New York|
|New York, New York, United States, 10032|
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Study Chair:||Jennifer Clarke, MD||University of California, San Francisco|