Expired Study
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Portland, Oregon 97213


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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven metastatic breast cancer - Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease) - Patients with advanced stage disease who: - Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease - Refused chemotherapy - Refused or progressed despite hormonal therapy - Measurable or evaluable disease - Positive or negative for HLA-A2 - Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible - No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months - No brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0 or 1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 Hepatic: - Not specified Renal: - BUN less than 25 mg/dL - Creatinine less than 1.8 mg/dL Cardiovascular: - No ischemic or congestive cardiac disease requiring chronic medication - No New York Heart Association class III or IV heart disease - No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG) - No evidence of type II arterial-ventricular block - No evidence of current cardiac disease by stress test and EKG Other: - HIV negative - No active infection requiring treatment - No psychiatric illness - No history of seizure disorder - No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered Endocrine therapy: - At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered Radiotherapy: - Concurrent radiotherapy allowed for local control of disease Surgery: - Not specified


NCT ID:

NCT00003184


Primary Contact:

Study Chair
Walter J. Urba, MD, PhD
Providence Cancer Center, Earle A. Chiles Research Institute


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97213
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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