Overview

This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments hsppc-96, conventional surgery
Phase phase 1/phase 2
Sponsor University of California, San Francisco
Collaborator National Cancer Institute (NCI)
Start date October 2005
End date December 2013
Trial size 50 participants
Trial identifier NCT00293423, 05103, P30CA082103, UCSF-05103, UCSF-H41995-27311-01

Summary

RATIONALE: 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.

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single-arm,(HSPPC-96) administered in combination with temozolomide following standard treatment with radiation and temozolomide.
hsppc-96 Heat Shock
25 mcg ID
conventional surgery
craniotomy

Primary Outcomes

Measure
Safety and maximum tolerated dose
time frame: survival
Frequency of gp96 heat shock protein-peptide complex vaccine (Phase I [closed to accrual as of 7/25/2007])
time frame: survival
Toxicity (Phase I [closed to accrual as of 7/25/2007])
time frame: survival
Progression-free survival at 6 months (Phase II)
time frame: 6 months

Secondary Outcomes

Measure
Immunological response (Phase I [closed to accrual as of 7/25/2007])
time frame: last vaccine
Safety (Phase II)
time frame: survival
Tumor response as measured by neuro-imaging and neurologic exam (Phase II)
time frame: survival
Survival (Phase II)
time frame: survival
Immunological response (Phase II)
time frame: survival

Eligibility Criteria

Male or female participants at least 18 years old.

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 SGPT ≤ 2.5 times normal - Bilirubin < 1.5 mg/dL - 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 cervic, 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

Additional Information

Official title Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of California, San Francisco.