Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-30 @ 6:11 PM
Study NCT ID:
NCT00003433
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
Sponsor:
Duke Cancer Institute
Organization:
Study Overview
Official Title:
A Phase I/II 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 person's body build an immune response to kill their tumor cells.
PURPOSE: Phase I/II 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 I/II 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 4.5 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 4.5 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: