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

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00003357
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-11
• Study Completion: 2001-11
• Study First Submitted QC: 2004-08-13
• Study First Posted: 2004-08-16
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States