|
Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer Clinical research trials and Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer  Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer
Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Donor lymphocytes may attack and destroy cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and donor lymphocyte infusion in treating women who have stage IV breast cancer.
Details: OBJECTIVES: I. Determine the tumor response in women with stage IV breast cancer who achieve partial remission after mini-conditioning comprised of fludarabine and cyclophosphamide, followed by allogeneic peripheral blood stem cell transplantation (PBSCT), and donor lymphocyte infusion (DLI). II. Determine the progression free survival in patients who achieve complete remission after this treatment regimen. III. Determine whether DLI exerts graft versus tumor effect in these patients. IV. Determine the acute and delayed toxicities of this regimen in these patients. V. Determine the rates of durable hematologic engraftment in patients treated with this regimen. VI. Determine the incidence and severity of acute and chronic graft versus host disease in patients treated with this regimen. VII. Determine the extent of chimerism in patients treated with this nonmyeloablative conditioning regimen. VIII. Determine the rate and quality of immune reconstitution in patients treated with this regimen. IX. Determine the event free and overall survival in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive salvage chemotherapy comprised of docetaxel IV over 1 hour and doxorubicin IV over several minutes on day 1. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning within 4-10 weeks after completion of salvage chemotherapy, patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive filgrastim (G-CSF) and sargramostim (GM-CSF) mobilized allogeneic peripheral blood stem cells (PBSC) IV on day 0. Beginning on day 120 after PBSC transplantation, eligible patients receive unmobilized donor lymphocyte infusion (DLI) over 15-30 minutes. Treatment continues monthly for a total of 3 DLIs in the absence of grade III or IV graft versus host disease or marrow aplasia. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage IV epithelial breast cancer; Must meet one of the following conditions: Complete or partial remission or stable disease following chemotherapy or radiotherapy; Previously untreated disease - No progressive disease after prior therapy for metastatic breast cancer - Overexpression of HER2 protein (2+ or 3+ by immunohistochemistry) allowed if failed prior trastuzumab (Herceptin) therapy - Measurable disease by physical exam or external imaging studies OR Evaluable disease (e.g., abnormal bone scan) - Availability of a suitable HLA-A, B, and DR phenotypically identical sibling donor - No active CNS disease - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; No prior autologous stem cell transplantation - Chemotherapy: See Disease Characteristics; No prior docetaxel; At least 3 weeks since other prior chemotherapy; Prior doxorubicin allowed if cumulative dose less than 250 mg/m2; Prior paclitaxel allowed; No more than 1 prior salvage chemotherapy regimen for metastatic disease - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 60 - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0 or 1; Karnofsky 80-100% - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1,000/mm3*; Platelet count at least 100,000/mm3* * In patients receiving docetaxel - Hepatic: SGOT and SGPT no greater than 5 times upper limit of normal (ULN)* Bilirubin no greater than ULN*; Alkaline phosphatase no greater than 2.5 times ULN; Alkaline phosphatase no greater than 4 times ULN if SGOT and SGPT no greater than ULN * In patients receiving docetaxel - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min - Cardiovascular: Left ventricular ejection fraction at least 40% by MUGA scan; No cerebrovascular accident - Pulmonary: DLCO, FVC, and FEV1 at least 60% predicted - Other: No active infection; Not pregnant or nursing; Negative pregnancy test; HIV negative; No history of allergic reaction to taxane or polysorbate 80; No grade 2 or worse peripheral neuropathy; No second malignancy within the past 2 years except basal cell skin cancer, carcinoma in situ of the cervix, or tumor previously treated with curative intent; No other clinically significant comorbid illnesses
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HillardLazarus, Study Chair, Ireland Cancer Center
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Additional Information:
Study ID Numbers: CDR0000068197; CWRU-1199,NCI-G00-1855
Study Start Date: May 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006261
Other Recurrent Breast Cancer Studies:
1. Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
2. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
3. Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
4. Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
5. Vaccine Therapy in Treating Women With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer
|
|
|
|
|
|
|
|
