Trial record 4 of 12 for:
HSPPC-96
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
Andrew Parsa, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00293423
First received: February 16, 2006
Last updated: January 14, 2013
Last verified: January 2013
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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: | Allocation: Non-Randomized 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:
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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2005 |
| Estimated Primary Completion Date: | December 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
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
Investigators
| Study Chair: | Andrew T. Parsa, MD, PhD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| Responsible Party: | Andrew Parsa, Andrew T. Parsa, MD, PhD, UCSF Department of Neurosurgery, 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: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Antigenics, Inc. |
Keywords provided by 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 Neoplasms Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013