Breast Cancer Clinical Trial
Vaccine Therapy in Treating Women With Metastatic 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.
Full Description
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
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There is 1 Location for this study
Portland Oregon, 97213, United States
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