Pancreatic Cancer Clinical Trial
Official title:
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
Rational: White blood cells that have been treated with carcinoembryonic antigen peptide-1
may help the body build an immune response to and kill tumor cells that express CEA.
Purpose: Phase II trial to study the effectiveness of white blood cells plus
carcinoembryonic antigen peptide-1 in treating patients with stage I, stage II, or stage III
pancreatic cancer that has been surgically removed.
Objective: 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.
Project Accrual: A total of 24 patients will be accrued for this study over 2 years.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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