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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00293423
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : August 21, 2017
National Cancer Institute (NCI)
Agenus Inc.
Information provided by (Responsible Party):
Jennifer Clarke, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: HSPPC-96 Procedure: conventional surgery Phase 1 Phase 2

Detailed Description:



  • 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)


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma
Study Start Date : October 2005
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vaccine with Chemotherapy
Single-arm,(HSPPC-96) administered in combination with temozolomide following standard treatment with radiation and temozolomide.
Biological: HSPPC-96
25 mcg ID
Other Name: Heat Shock
Procedure: conventional surgery

Primary Outcome Measures :
  1. Safety and maximum tolerated dose [ Time Frame: survival ]
  2. Frequency of gp96 heat shock protein-peptide complex vaccine (Phase I [closed to accrual as of 7/25/2007]) [ Time Frame: survival ]
  3. Toxicity (Phase I [closed to accrual as of 7/25/2007]) [ Time Frame: survival ]
  4. Progression-free survival at 6 months (Phase II) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Immunological response (Phase I [closed to accrual as of 7/25/2007]) [ Time Frame: last vaccine ]
  2. Safety (Phase II) [ Time Frame: survival ]
  3. Tumor response as measured by neuro-imaging and neurologic exam (Phase II) [ Time Frame: survival ]
  4. Survival (Phase II) [ Time Frame: survival ]
  5. Immunological response (Phase II) [ Time Frame: survival ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293423

United States, California
UCSF Department of Neurosurgery
San Francisco, California, United States, 94143
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Agenus Inc.
Study Chair: Jennifer Clarke, MD University of California, San Francisco

Responsible Party: Jennifer Clarke, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00293423     History of Changes
Other Study ID Numbers: 05103
P30CA082103 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Jennifer Clarke, University of California, San Francisco:
adult glioblastoma
recurrent adult brain tumor

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Immunologic Factors
Physiological Effects of Drugs