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
OBJECTIVES: 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 4.5 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.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study over 2 years.
Primary Purpose: Treatment
Michael A. Morse, MD
United States: Federal Government
|Duke Comprehensive Cancer Center
|Durham, North Carolina 27710