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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and maximum tolerated dose

Outcome Time Frame:


Safety Issue:


Principal Investigator

Andrew T. Parsa, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • recurrent adult brain tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Columbia University New York, New York  10032-3784
UCSF Department of Neurosurgery San Francisco, California  94143
University Hospitals Case Medical Center Cleveland, Ohio  44106