Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003025
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Pilot Trial of Immunotherapy With Autologous Tumor-Derived gp96 Heat Shock Protein - Peptide Complex HSPPC-96 in Patients With Resected Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-07
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:
RATIONALE Vaccines made from a persons cancer cells may make the body build an immune response to and kill tumor cells Combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed
Detailed Description:
OBJECTIVES I Study the safety of autologous tumor derived gp96 heat shock protein peptide complex HSPPC-96 in patients with resected pancreatic adenocarcinoma II Examine the immune response to HSPPC-96 in this group of patients
OUTLINE This is a dose escalation study Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex HSPPC-96 subcutaneously once a week for 4 weeks Five patients are initially enrolled at each of two dose levels An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96 Patients are followed at weeks 1 4 and 12 after treatment
PROJECTED ACCRUAL A maximum of 16 patients will be accrued for this study
OUTLINE This is a dose escalation study Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex HSPPC-96 subcutaneously once a week for 4 weeks Five patients are initially enrolled at each of two dose levels An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96 Patients are followed at weeks 1 4 and 12 after treatment
PROJECTED ACCRUAL A maximum of 16 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-G97-1271 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065613 | REGISTRY | None | None |
| ANTIGENICS-C-100-01 | None | None | None |