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

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. This phase I/II trial is studying the side effects and best dose of gp96 heat shock protein-peptide complex vaccine to see how well it works in treating patients with recurrent or progressive high-grade glioma over time.

PRIMARY OBJECTIVES:

* Phase 1: \[closed to accrual as of 7/25/2007\]: 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 2: Determine the clinical response to treatment, time to disease recurrence and progression, and overall survival of patients treated with this vaccine.

SECONDARY OBJECTIVES:

* Determine the immune response in patients treated with this vaccine.
* Determine survival outcomes 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 underwent 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 at least 4 doses and then every 2-3 weeks thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. Cohorts of 6 patients received the HSPPC-96 vaccine at escalating dose frequencies until the maximum tolerated dose (MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experienced a dose-limiting toxicity.

PHASE II: Patients received 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). The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for at least 4 doses and then every 2 weeks thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. After completion of study treatment, patients are followed periodically until death, lost to follow-up, or end of study.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant recurrent glioma\*, including any of the following:

  * Glioblastoma

    * Glioblastoma multiforme
* Recurrent disease or progressive primary disease
* Surgically accessible tumor for which surgical resection is indicated and has not been previously irradiated
* Prior radiotherapy required
* No prior oncophage therapy or immunotherapy for glioma

PATIENT CHARACTERISTICS:

* Karnofsky performance status 80-100%
* Life expectancy ≥ 8 weeks
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Alkaline phosphatase and serum glutamic-pyruvic transaminase (SGPT) \<=2.5 times normal
* Bilirubin \< 1.5 mg/dL
* Blood Urea Nitrogen (BUN) \< 1.5 times normal OR creatinine \< 1.5 times normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 4 weeks after completion of study treatment
* No uncontrolled active infection
* No bleeding diathesis
* No psychiatric or medical situation that would preclude study compliance
* No unstable or severe concurrent medical condition
* No other cancer or concurrent malignancy within the past 5 years except adequately treated nonmetastatic in situ carcinoma of the uterine cervix, nonmetastatic nonmelanoma skin cancer, or in complete remission and off all therapy for that disease
* No systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 2 weeks since prior vincristine
* At least 6 weeks since prior nitrosoureas
* At least 4 weeks since prior temozolomide or other cytotoxic chemotherapy
* At least 4 weeks since prior investigational agents
* At least 1 week since prior noncytotoxic agents
* At least 3 weeks since prior procarbazine
* No radiotherapy within the past 4 weeks