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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Women With Metastatic Breast Cancer  Biological Therapy in Treating Women With Metastatic Breast Cancer
Biological Therapy in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,stage 3B breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): St. Luke's Medical Center ,
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer.
Details: OBJECTIVES: I. Evaluate the toxicities of the combination of low dose interleukin-2 (IL-2) sargramostim (GM-CSF), and multiple doses of activated T cells (ATC) following peripheral blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the breast. II. Evaluate the efficacy of this regimen in these patients. PROTOCOL OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days prior to peripheral blood stem cell (PBSC) collection or for 2 days prior to bone marrow harvest. Following PBSC collection or bone marrow harvest, patients receive high dose chemotherapy consisting of cyclophosphamide IV, carboplatin IV, and thiotepa IV over days -6 through -3. Patients undergo PBSC transplantation on day 0. Following PBSC transplantation, patients receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour between days 1 and 65, continuous low dose interleukin-2 (IL-2) IV over days 1-65, and sargramostim (GM-CSF) subcutaneously on days 5-21. Patients are followed at day 100, as clinically indicated, and then annually. PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically documented metastatic adenocarcinoma of the breast; Concurrent intraductal or lobular carcinoma in situ allowed; Bilateral disease allowed - Measurable or evaluable recurrent metastatic disease (Stage IIIB or IV) documented by radiograph, CT scan, nuclear medicine scan, or physical exam - Tumor must be clinically chemosensitive as documented by a reduction in tumor burden - No clinical evidence of brain metastases --Prior/Concurrent Therapy-- - See Disease Characteristics - No concurrent hormonal therapy for breast cancer --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 50,000/mm3; Hemoglobin at least 8 g/dL - Hepatic: Bilirubin less than 1.5 times normal; Hepatitis B surface antigen negative - Renal: Creatinine less than 1.8 mg/dL; Creatinine clearance normal; Blood urea nitrogen (BUN) less than 1.5 times normal - Cardiovascular: Ejection fraction at least 45% by MUGA; No uncontrolled or significant cardiovascular disease including myocardial infarction (less than 1 year) or congestive heart failure - Pulmonary: PFT-FEV1 at least 60% of predicted; DLCO and FVC at least 60% of predicted - Other: Not pregnant; Negative pregnancy test; HIV negative; No serious medical or psychiatric illness; No prior or concurrent malignancy, other than curatively treated carcinoma in situ of the cervix or basal cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnHanson, Study Chair, St. Luke's Medical Center
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Additional Information:
Study ID Numbers: CDR0000064792; STLMC-BRM-9503,NCI-V96-0902
Study Start Date: May 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002780
Other Stage 4 Breast Cancer Studies:
1. Anastrozole With or Without Trastuzumab in Treating Postmenopausal Women With Metastatic Breast Cancer
2. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
3. ICI 182780 in Treating Women With Metastatic Breast Cancer
4. Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
5. Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Biological Therapy in Treating Women With Metastatic Breast Cancer
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