gp96 heat shock protein-peptide complex vaccine in treating patients with recurrent or progressive glioma

Conditions: Brain and Central Nervous System Tumors

Summary: 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

Keywords: adult glioblastoma recurrent adult brain tumor