Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer
BCG vaccine
+ CD80 breast cancer vaccine
+ sargramostim
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: August 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, United StatesOpen Earle A. Chiles Research Institute at Providence Portland Medical Center in Google Maps