Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer

Fecha de inicio: 1 de agosto de 1996

DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease) Patients with advanced stage disease who: Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease Refused chemotherapy Refused or progressed despite hormonal therapy Measurable or evaluable disease Positive or negative for HLA-A2 Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months No brain metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Hepatic: Not specified Renal: BUN less than 25 mg/dL Creatinine less than 1.8 mg/dL Cardiovascular: No ischemic or congestive cardiac disease requiring chronic medication No New York Heart Association class III or IV heart disease No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG) No evidence of type II arterial-ventricular block No evidence of current cardiac disease by stress test and EKG Other: HIV negative No active infection requiring treatment No psychiatric illness No history of seizure disorder No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered Endocrine therapy: At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered Radiotherapy: Concurrent radiotherapy allowed for local control of disease Surgery: Not specified