Vaccine Therapy in Treating Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00003184|
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: BCG vaccine Biological: CD80 breast cancer vaccine Biological: sargramostim||Phase 1|
- 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 Type :||Interventional (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|
|Study Start Date :||August 1996|
|Actual Study Completion Date :||July 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003184
|United States, Oregon|
|Earle A. Chiles Research Institute at Providence Portland Medical Center|
|Portland, Oregon, United States, 97213-2967|
|Study Chair:||Walter J. Urba, MD, PhD||Providence Cancer Center, Earle A. Chiles Research Institute|