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
- 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.
Primary Purpose: Treatment
Herbert K. Lyerly, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|