Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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.
|Colorectal Cancer Metastatic Cancer||Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||June 1998|
|Study Completion Date:||August 2003|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003433
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Herbert K. Lyerly, MD||Duke Cancer Institute|