GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma
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|ClinicalTrials.gov Identifier: NCT00293423|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : August 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: HSPPC-96 Procedure: conventional surgery||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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 Shock
Procedure: conventional surgery
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|