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T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer Clinical research trials and T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer  T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,Male Breast Cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Reducing the dose of drugs used in chemotherapy may decrease side effects. Allogeneic stem cell transplantation may be effective in killing metastatic tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of combining T-cell-depleted (T-cells removed) donor stem cell transplantation followed by treated donor lymphocytes given after induction chemotherapy and reduced-intensity conditioning (low doses of chemotherapy given before the transplant) in treating patients who have metastatic breast cancer.
Details: OBJECTIVES: Primary - Determine the safety, in terms of the incidence of acute graft-versus-host disease, and feasibility of using in vitro-generated donor T cells of Th2/Tc2 phenotype to augment a T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning in patients with metastatic breast cancer. Secondary - Determine the effect of this treatment regimen on donor chimerism in these patients. - Determine the effect of this treatment regimen on clinical response in these patients. - Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of Th2/Tc2 cells. - Immunoablative induction chemotherapy: Patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover. In order to achieve the greatest immunosuppression before transplantation, patients may receive a second course of immunoablative induction chemotherapy beginning on day 21 depending on CD4+ count. - Transplantation preparative regimen: Beginning 7-21 days after recovery from induction chemotherapy, patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 before transplantation. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours or orally every 12 hours beginning on day -1 and continuing until day 28, followed by a taper until day 40. - Allogeneic stem cell transplantation (SCT): Patients undergo T-cell-depleted allogeneic peripheral blood SCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. - Donor Th2/Tc2 cell administration: Patients receive donor Th2/Tc2 cells IV on day 0 after SCT. Cohorts of 6-12 patients receive escalating doses of donor Th2/Tc2 cells until feasibility is determined. Feasibility is defined as the dose level at which no more than 6 of 12 patients experience grade II-IV acute GVHD by day 42 post-transplantation. - Donor lymphocyte infusion (DLI): Patients with progressive malignant disease and less than grade II acute GVHD at day 42 post-transplantation may receive DLI on days 42, 70, and 98. Patients are followed every 2 weeks until approximately day 100 and then at 6, 9, 12, 18 and 24 months. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage IV breast cancer - Measurable disease - Received at least 1 prior chemotherapy regimen for treatment of distant metastases and achieved less than a complete response - Must have received prior therapy with a taxane (e.g., paclitaxel) and an anthracycline (e.g., doxorubicin) either as adjuvant therapy or as treatment of metastatic disease - If tumor expresses Her2-neu, patient must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting - If tumor expresses estrogen and/or progesterone receptors, patient must have received at least 1 hormonal therapy (e.g., tamoxifen) in either the adjuvant or metastatic setting - CNS metastases allowed if treated and stable for at least 4 weeks after completion of therapy - Consenting sibling donor with 6 of 6 matching HLA antigens - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 to 75 Sex - Not specified Menopausal status - Not specified Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 6 months Hematopoietic - Not specified Hepatic - Bilirubin 2.5 mg/dL* - SGOT < 4 times upper limit of normal* - Hepatitis B surface antigen negative - Hepatitis C antibody negative NOTE: *Unless due to liver involvement by malignancy Renal - Creatinine 1.5 mg/dL - Creatinine clearance 50 mL/min Cardiovascular - LVEF 45% by MUGA or 2-dimensional echocardiogram Pulmonary - DLCO 50% of expected value (corrected for hemoglobin) Other - HIV negative - No active infection that does not respond to antimicrobial therapy - No history of a psychiatric disorder that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 1 year after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Prior autologous stem cell transplantation allowed Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelBishop, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000361744; NCI-04-C-0131
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082953
Other Male Breast Cancer Studies:
1. PS-341 in Treating Women With Metastatic Breast Cancer
2. Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
3. Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
4. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
5. Letrozole With or Without CCI-779 in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other Male Breast Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
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