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

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	Biological: HSPPC-96 Procedure: conventional surgery	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Shock

Genetic and Rare Diseases Information Center resources: Brain Tumor, Adult Glioblastoma Glioma

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	41
Study Start Date:	October 2005
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 craniotomy

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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.

Investigators


Study Chair:	Jennifer Clarke, MD	University of California, San Francisco

More Information

Additional Information:

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

No publications provided


Responsible Party:	Jennifer Clarke, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00293423 History of Changes
Other Study ID Numbers:	05103, P30CA082103, UCSF-05103, UCSF-H41995-27311-01
Study First Received:	February 16, 2006
Last Updated:	November 12, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:


adult glioblastoma recurrent adult brain tumor

Additional relevant MeSH terms:


Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases

ClinicalTrials.gov processed this record on February 27, 2015