Clinical Trial Finder

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

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.

Arms

Experimental: Phase 1: Vaccine

Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.

Experimental: Phase 2: Vaccine

Treatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.

Interventions

Biological: - HSPPC-96

25 mcg

Procedure: - Standard Surgical Resection

Patients will undergo standard surgical resection of intracranial tumor