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

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00293423

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: vitespen Procedure: conventional surgery	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Oncophage

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety and maximum tolerated dose [ Designated as safety issue: Yes ]
Frequency of gp96 heat shock protein-peptide complex vaccine (Phase I [closed to accrual as of 7/25/2007]) [ Designated as safety issue: No ]
Toxicity (Phase I [closed to accrual as of 7/25/2007]) [ Designated as safety issue: Yes ]
Progression-free survival at 6 months (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunological response (Phase I [closed to accrual as of 7/25/2007]) [ Designated as safety issue: No ]
Safety (Phase II) [ Designated as safety issue: Yes ]
Tumor response as measured by neuro-imaging and neurologic exam (Phase II) [ Designated as safety issue: No ]
Survival (Phase II) [ Designated as safety issue: No ]
Immunological response (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2005
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293423

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Andrew T. Parsa, MD, PhD

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	UCSF Helen Diller Family Comprehensive Cancer Center ( Andrew T. Parsa )
Study ID Numbers:	CDR0000456628, UCSF-05103, UCSF-H41995-27311-01
Study First Received:	February 16, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00293423
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
recurrent adult brain tumor

Study placed in the following topic categories:

Brain Neoplasms
Glioblastoma
Shock
Glioma

Central Nervous System Neoplasms
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009