Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer
- Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen
synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune
response in patients with stage IIB, III, or IV colorectal cancer.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen
synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day
22, patients undergo removal of the lymph node into which the vaccination site drains to
determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Safety of the 4-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 22
Charles M. Friel, MD
University of Virginia
United States: Federal Government
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|