A Trial Of Vaccination With The Carcinoembryonic Antigen (CEA) Peptide Cap 1-6D With Montanide ISA 51 Adjuvant Or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) In HLA-A2+ Patients With CEA Producing Adenocarcinomas Of Gastrointestinal (GI) Tract Origin
- Determine whether immunization with carcinoembryonic antigen (CEA) peptide 1-6D (CAP
1-6D) emulsified in Montanide ISA-51 adjuvant or dissolved in sargramostim (GM-CSF) can
generate CAP 1-6D-specific T cells in patients with CEA-producing adenocarcinomas of
gastrointestinal tract origin.
- Determine whether vaccination with CAP 1-6D can generate cytotoxic T cells against
CEA-expressing tumors in these patients.
- Determine whether this vaccine can produce antitumor responses in these patients.
- Determine the frequency and severity of toxic effects associated with this vaccine in
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carcinoembryonic antigen peptide 1-6D (CAP 1-6D) emulsified in
Montanide ISA-51 adjuvant subcutaneously on day 1.
- Arm II: Patients receive CAP 1-6D dissolved in sargramostim (GM-CSF) intradermally on
Treatment repeats in both arms every 3 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed at 3 weeks and then as necessary.
PROJECTED ACCRUAL: A total of 10-36 patients (5-18 per arm) will be accrued for this study
within 36 months.
Allocation: Randomized, Primary Purpose: Treatment
Production of CAP 1-6D T cells
Robert P. Whitehead, MD
University of Texas
United States: Food and Drug Administration
|University of Texas Medical Branch||Galveston, Texas 77555-1329|