Vaccine Therapy Plus QS21 in Treating Women With Breast Cancer Who Have No Evidence of Disease
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|ClinicalTrials.gov Identifier: NCT00003357|
Recruitment Status : Completed
First Posted : August 16, 2004
Last Update Posted : December 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: GM2-KLH vaccine Biological: QS21||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Official Title:||Vaccination of High Risk Breast Cancer Patients Lacking Identifiable Disease With GM2-KLH Conjugate Plus the Immunological Adjuvant QS21|
|Study Start Date :||January 1998|
|Actual Primary Completion Date :||November 2001|
|Actual Study Completion Date :||November 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003357
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Teresa Ann Gilewski, MD||Memorial Sloan Kettering Cancer Center|