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



Status:Archived
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma


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.


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.


We found this trial at
3
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722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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San Francisco, CA
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