Finding studies
Finding studies
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Lead
Providence Cancer Center, Earle A. Chiles Research Institute
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
