Spots Global Cancer Trial Database for Vaccine Therapy Plus QS21 in Treating Women With Breast Cancer Who Have No Evidence of Disease

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Trial Identification

Brief Title: Vaccine Therapy Plus QS21 in Treating Women With Breast Cancer Who Have No Evidence of Disease

Official Title: Vaccination of High Risk Breast Cancer Patients Lacking Identifiable Disease With GM2-KLH Conjugate Plus the Immunological Adjuvant QS21

Study ID: NCT00003357

Conditions

Breast Cancer

Interventions

GM2-KLH vaccine

QS21

Study Description

Brief Summary: RATIONALE: Vaccines made from GM2-KLH and given with QS21 may make the body build an immune response to and kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of GM2-KLH vaccine plus QS21 in treating patients with breast cancer who have no evidence of disease.

Detailed Description: OBJECTIVES: I. Determine whether immunization with GM2-KLH vaccine plus the immunological adjuvant QS21 induces an antibody response against GM2 and cells expressing GM2 in disease free patients at high risk for recurrence of breast cancer. OUTLINE: GM2-KLH vaccine plus QS21 is administered subcutaneously to sites on the upper arm and upper leg at weekly intervals for 4 weeks. Two additional vaccines are administered at weeks 12 and 24. Patients are followed every 3 months after the sixth vaccination. PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study within 1 year.