Vaccination of High Risk Breast Cancer Patients With MUC-1 (Glycosylated) Keyhole Limpet Hemocyanin Conjugates Plus the Immunological Adjuvant QS21
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- immune response
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
Detailed Description
OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with high risk breast cancer expressing MUC-1. OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, and 19 for a total of 5 vaccinations. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
immune response
Time Frame: 2 years