Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003434
Status:
TERMINATED
Last Update Posted:
2014-02-10
First Post:
1999-11-01
Brief Title:
Biological Therapy in Stage I Stage II or Stage III Surgically Resected Pancreatic Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Pilot Study of Active Immunotherapy With Carcinoembryonic Antigen Peptide-Pulsed Autologous Human Cultured Dendritic Cells in Patients With Resected Stage I II and III Pancreatic Adenocarcinoma Expressing Carcinoembryonic Antigen
Status:
TERMINATED
Status Verified Date:
2014-02
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:
Rational White blood cells that have been treated with carcinoembryonic antigen peptide-1 may help the body build an immune response to and kill tumor cells that express CEA
Purpose Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic antigen peptide-1 in treating patients with stage I stage II or stage III pancreatic cancer that has been surgically removed
Purpose Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic antigen peptide-1 in treating patients with stage I stage II or stage III pancreatic cancer that has been surgically removed
Detailed Description:
Objective I Perform a pilot study of active immunotherapy with autologous dendritic cells pulsed with the CEA peptide CAP-1 after surgical resection in patients with CEA expressing pancreatic cancer II Perform laboratory analysis to monitor the presence persistence and function of CAP-1 specific T-cells in this patient population
Outline Patients undergo leukapheresis for up to 45 hours prior to vaccination Half of the collected dendritic cells are pulsed with carcinoembryonic antigen CEA peptide and the other half are pulsed with hepatitis B antigen peptide HBsAg Equal doses of CEA and HBsAg peptide pulsed dendritic cells are administered intravenously over 3 minutes every 4 weeks for a total of 6 doses each Patients undergo a second leukopheresis 2 weeks after the last dose of immunotherapy to obtain specimens for immunologic tests Patients are followed at weeks 22 36 48 and every 6 months thereafter
Project Accrual A total of 24 patients will be accrued for this study over 2 years
Outline Patients undergo leukapheresis for up to 45 hours prior to vaccination Half of the collected dendritic cells are pulsed with carcinoembryonic antigen CEA peptide and the other half are pulsed with hepatitis B antigen peptide HBsAg Equal doses of CEA and HBsAg peptide pulsed dendritic cells are administered intravenously over 3 minutes every 4 weeks for a total of 6 doses each Patients undergo a second leukopheresis 2 weeks after the last dose of immunotherapy to obtain specimens for immunologic tests Patients are followed at weeks 22 36 48 and every 6 months thereafter
Project Accrual A total of 24 patients will be accrued for this study over 2 years
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 |
|---|---|---|---|
| CDR0000066460 | OTHER | NCI | None |
| DUMC-97093 | None | None | None |
| NCI-G98-1457 | None | None | None |