vaccine therapy in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: vaccines made from breast cancer cells may make the body build an immune response to kill tumor cells. purpose: phase i trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer.

objectives: * determine the safety and toxicity of vaccination strategies employing a cd80-transfected allogeneic breast cancer cell line (mda-mb-231). * assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of cd80-transfected mda-mb-231. * assess the development of systemic immunity following multiple injections of cd80-transfected mda-mb-231. * observe for tumor regression. outline: this is a dose-escalation study. patients receive intradermal vaccinations containing cd80-transfected cells with or without sargramostim (gm-csf) or with or without bcg. vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months. patients may receive 1 of 2 different doses of gm-csf. gm-csf is administered with the vaccination, then every 12 hours for 7 days. monthly vaccinations may continue as long as response is shown. cohorts of 5 patients each are treated at each dose/combination. each cohort completes treatment before the next cohort is accrued. patients are followed at weeks 4 and 8, then every 2 months for 6 months, then every 3 months for 1 year, and then every 6 months until disease progression. projected accrual: approximately 35 patients will be accrued for this study within 18 months.

Eligibility criteria:
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

Keywords: stage iv breast cancer recurrent breast cancer