Breast Cancer Clinical Trial
Official title:
Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer
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.
;
Primary Purpose: Treatment
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