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| Sponsor: | Providence Cancer Center, Earle A. Chiles Research Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003184 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: BCG vaccine Biological: CD80 breast cancer vaccine Biological: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven metastatic breast cancer
Patients with advanced stage disease who:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000066010, PPMC-IRB-94-78, OCC-ONC-9408-L, NCI-V98-1379 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003184 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
BCG Vaccine Neoplasms Neoplasms by Site Immunologic Factors Skin Diseases |
Physiological Effects of Drugs Adjuvants, Immunologic Breast Neoplasms Pharmacologic Actions Breast Diseases |