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
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Craig L Slingluff, Jr
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Safety of the 4-peptide mixture
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.
Detailed Description
OBJECTIVES: * 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.
Investigators
Craig L Slingluff, Jr
Director, Human Immune Therapy Center
University of Virginia
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety of the 4-peptide mixture
Time Frame: 30 days following last vaccine
Adverse events
Number of patients with an immune response to the peptides
Time Frame: through Day 22
T cell responses against the peptides as measured in the sentinel immunized node
Secondary Outcomes
- Immunogenicity of the peptide mixture measured in the peripheral blood(through Day 22)