Breast Cancer Clinical Trial
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
Full Description
OBJECTIVES:
Primary
Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
Determine the IgG and IgM antibody response to this regimen in these patients.
Determine the proportion of breast cancer cells expressing this antigen in these patients.
Secondary
Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.
OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
No evidence of disease
Stable disease on hormonal therapy
Stable disease must be present for ≥ 2 months and include < 30% decrease or < 20% increase in the sum of the longest diameter of target lesion
No new target lesions or unequivocal progression of non-target lesions
Elevation in the CA 153 (BR2729) or CEA values allowed
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Female or male
Menopausal status not specified
Karnofsky performance status 80-100%
Lymphocyte count ≥ 500/mm³
WBC ≥ 3,000/mm³
Creatinine ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 1.5 times ULN
Alkaline phosphatase ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of allergy to seafood
No NYHA class III-IV cardiac disease
No other active cancers except basal cell or squamous cell carcinoma of the skin
No active infection requiring antibiotic treatment
No known history of immunodeficiency or autoimmune disease
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 4 weeks since prior chemotherapy
At least 4 weeks since prior radiotherapy
At least 4 weeks since prior surgery
At least 6 weeks since prior immunotherapy
No prior sialyl Lewisª antigen
No concurrent immunosuppressive medications (i.e., corticosteroids)
Concurrent hormonal therapy allowed
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There is 1 Location for this study
New York New York, 10065, United States
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