NCT00003184

Vaccine Therapy in Treating Women With Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Providence Cancer Center, Earle A. Chiles Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BCG vaccine
BIOLOGICAL	CD80 breast cancer vaccine
BIOLOGICAL	sargramostim

Timeline

• Start date: 1996-08-01
• Completion: 2003-07-01
• First posted: 2003-07-11
• Last updated: 2013-04-04

Locations

1 site across 1 country: United States