Vaccine Therapy in Treating Women With Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00003184
• Lead Sponsor: Providence Cancer Center, Earle A. Chiles Research Institute

Brief 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.

Study Timeline

• Study Start: 1996-08
• Study First Submitted: 1999-11-01
• Status Verified: 2000-11
• Study Completion: 2003-07
• Study First Submitted QC: 2003-07-10
• Study First Posted: 2003-07-11
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Earle A. Chiles Research Institute at Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States