Vaccine Therapy in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: BCG vaccine
* Biological: CD80 breast cancer vaccine
* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG vaccine|nan|
|Biological: CD80 breast cancer vaccine|nan|
|Biological: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer