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

NCT ID: NCT00003357

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2001-11-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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stage I breast cancer stage II breast cancer stage III breast cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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GM2-KLH vaccine

Intervention Type BIOLOGICAL

QS21

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Premenopausal or postmenopausal Performance status: Karnofsky 90-100% Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 500/mm3 WBC count at least 3,000/mm3 Hepatic: Aspartate aminotransferase no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent active cancers except basal cell or squamous cell carcinomas of the skin No history of a seafood allergy No known history of immunodeficiency or autoimmune disease

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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Teresa Ann Gilewski, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MSKCC-97123

Identifier Type: -

Identifier Source: secondary_id

NCI-H98-0015

Identifier Type: -

Identifier Source: secondary_id

97-123

Identifier Type: -

Identifier Source: org_study_id