Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

Inclusion 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