Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and maximum tolerated dose
Andrew T. Parsa, MD, PhD
University of California, San Francisco
United States: Food and Drug Administration
|Columbia University||New York, New York 10032-3784|
|UCSF Department of Neurosurgery||San Francisco, California 94143|
|University Hospitals Case Medical Center||Cleveland, Ohio 44106|