GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma

OBJECTIVES:

Primary

- 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)

Secondary

- 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.