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Status:

COMPLETED

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

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

National Cancer Institute (NCI)

Agenus Inc.

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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 ...

Detailed Description

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 re...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 18 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 12 2013

    Estimated Enrollment :

    96 Patients enrolled

    Trial Details

    Trial ID

    NCT00293423

    Start Date

    November 18 2005

    End Date

    January 12 2013

    Last Update

    May 13 2021

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    University of California, San Francisco

    San Francisco, California, United States, 94143

    2

    Columbia University

    New York, New York, United States, 10032

    3

    University Hospitals Case Medical Center

    Cleveland, Ohio, United States, 44106