Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 56
- Locations
- 75
- Primary Endpoint
- Recurrence free survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.
Detailed Description
OBJECTIVES: Primary * Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine. Secondary * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Beginning 6-12 weeks after curative hepatic resection, patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1, 15, 29, and 45, then subcutaneously monthly for 4 months. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 9 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recurrence free survival
Time Frame: 2 years
Secondary Outcomes
- Toxicity(5 years)