Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003433
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
Sponsor:
Duke Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed Autologous Cultured Dendritic Cells After Complete Resection of Hepatic Metastases of Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2002-11
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 Immunotherapy using CEA-treated white blood cells may help a persons body build an immune response to kill their tumor cells
PURPOSE Phase III trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with resected liver metastases from colon cancer
PURPOSE Phase III trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with resected liver metastases from colon cancer
Detailed Description:
OBJECTIVES
Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic cells in patients with adenocarcinoma of the colon metastatic to the liver
Evaluate the overall and recurrence free survival in this patient population
OUTLINE Patients undergo leukapheresis for up to 45 hours to collect dendritic cells The separated dendritic cells are pulsed with carcinoembryonic antigen CEA RNA Patients receive CEA RNA pulsed dendritic cells intravenously every 2 weeks for a total of 4 doses Patients undergo a second leukapheresis 2 weeks after the last dendritic cell infusion to obtain specimens for immunologic tests Patients with extra doses of dendritic cells available may receive additional doses of CEA RNA pulsed dendritic cells every 2 months in the absence of unacceptable toxicity
Patients are followed at weeks 12 24 36 and 48 and every 6 months thereafter
PROJECTED ACCRUAL A total of 22 patients will be accrued for this study over 2 years
Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic cells in patients with adenocarcinoma of the colon metastatic to the liver
Evaluate the overall and recurrence free survival in this patient population
OUTLINE Patients undergo leukapheresis for up to 45 hours to collect dendritic cells The separated dendritic cells are pulsed with carcinoembryonic antigen CEA RNA Patients receive CEA RNA pulsed dendritic cells intravenously every 2 weeks for a total of 4 doses Patients undergo a second leukapheresis 2 weeks after the last dendritic cell infusion to obtain specimens for immunologic tests Patients with extra doses of dendritic cells available may receive additional doses of CEA RNA pulsed dendritic cells every 2 months in the absence of unacceptable toxicity
Patients are followed at weeks 12 24 36 and 48 and every 6 months thereafter
PROJECTED ACCRUAL A total of 22 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 |
|---|---|---|---|
| NCI-G98-1456 | None | None | None |
| DUMC-2031-00-11R3 | None | None | None |
| DUMC-2176-99-12R2 | None | None | None |
| DUMC-97146 | None | None | None |