Vaccine Therapy in Treating Women With Metastatic Breast Cancer
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | July 2003 |
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.
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
- 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
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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003184 History of Changes |
| Other Study ID Numbers: | CDR0000066010, PPMC-IRB-94-78, OCC-ONC-9408-L, NCI-V98-1379 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
BCG Vaccine Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013