Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293423
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2006-02-16
Brief Title:
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase III Trial of Heat Shock Protein Peptide Complex-96 HSPPC-96 Vaccine for Patients With Recurrent High Grade Glioma
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vaccines made from a persons 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 III trial is studying the side effects and best dose of gp96 heat shock protein-peptide complex vaccine to see how well it works in treating patients with recurrent or progressive high-grade glioma over time
Detailed Description:
PRIMARY OBJECTIVES
Phase 1 closed to accrual as of 7252007 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 2 Determine the clinical response to treatment time to disease recurrence and progression and overall survival of patients treated with this vaccine
SECONDARY OBJECTIVES
Determine the immune response in patients treated with this vaccine
Determine survival outcomes in patients treated with this vaccine
OUTLINE This is a dose-escalation phase I study closed to accrual as of 7252007 followed by a phase II study
PHASE I closed to accrual as of 7252007
Patients underwent 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 at least 4 doses and then every 2-3 weeks thereafter in the absence of disease progression unacceptable toxicity or vaccine depletion Cohorts of 6 patients received the HSPPC-96 vaccine at escalating dose frequencies until the maximum tolerated dose MTD was determined The MTD is defined as the dose preceding that at which 2 of 6 patients experienced a dose-limiting toxicity
PHASE II Patients received the HSPPC-96 vaccine as in phase I at the appropriate dose frequency determined in phase I closed to accrual as of 7252007 The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for at least 4 doses and then every 2 weeks thereafter in the absence of disease progression unacceptable toxicity or vaccine depletion After completion of study treatment patients are followed periodically until death lost to follow-up or end of study
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Phase 1 closed to accrual as of 7252007 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 2 Determine the clinical response to treatment time to disease recurrence and progression and overall survival of patients treated with this vaccine
SECONDARY OBJECTIVES
Determine the immune response in patients treated with this vaccine
Determine survival outcomes in patients treated with this vaccine
OUTLINE This is a dose-escalation phase I study closed to accrual as of 7252007 followed by a phase II study
PHASE I closed to accrual as of 7252007
Patients underwent 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 at least 4 doses and then every 2-3 weeks thereafter in the absence of disease progression unacceptable toxicity or vaccine depletion Cohorts of 6 patients received the HSPPC-96 vaccine at escalating dose frequencies until the maximum tolerated dose MTD was determined The MTD is defined as the dose preceding that at which 2 of 6 patients experienced a dose-limiting toxicity
PHASE II Patients received the HSPPC-96 vaccine as in phase I at the appropriate dose frequency determined in phase I closed to accrual as of 7252007 The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for at least 4 doses and then every 2 weeks thereafter in the absence of disease progression unacceptable toxicity or vaccine depletion After completion of study treatment patients are followed periodically until death lost to follow-up or end of study
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA164714-02 | NIH | NCI Clinical Trials Reporting Program CTRP | httpsreporternihgovquickSearchR01CA164714-02 |
| UCSF-H41995-27311-01 | OTHER | None | None |
| NCI-2011-01231 | REGISTRY | None | None |
| P50CA097257-06 | NIH | None | None |