Breast Cancer Clinical Trial
Official title:
Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21
RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence
of breast cancer.
PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who
are at high risk for breast cancer recurrence.
OBJECTIVES:
- Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y,
TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet
hemocyanin plus QS21 induces an antibody response against these individual antigens and
breast cancer cells expressing these antigens in patients at high risk for breast
cancer recurrence.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate
vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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