Vaccine Therapy in Treating Patients With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: MUC1-KLH vaccine/QS21
- Registration Number
- NCT00004156
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccine: MUC1-KLH vaccine/QS21 MUC1-KLH vaccine/QS21 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.
- Primary Outcome Measures
Name Time Method immune response 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States