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Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer Clinical research trials and Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer health trials occur in a lot of of places 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer. Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer  Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer
Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer
For Condition: childhood non-Hodgkin's lymphoma,childhood Hodgkin's lymphoma,hematopoietic and lymphoid cancer
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells from a donor can be rejected by the body's normal cells. Mycophenolate mofetil and cyclosporine may prevent this from happening. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and fludarabine followed by donor peripheral stem cell transplantation, mycophenolate mofetil, and cyclosporine in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the rate of grade III/IV graft-versus-host disease (GVHD) in patients with hematologic malignancies treated with low-dose radiotherapy and fludarabine followed by allogeneic peripheral blood stem cell transplantation, mycophenolate mofetil, and cyclosporine. - Determine the risk of graft rejection and GVHD in patients treated with this regimen. - Determine the non-relapse mortality and disease response in patients treated with this regimen. - Determine the incidence and severity of infectious complications in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment regimens according to disease risk (indolent vs aggressive). Patients may receive cytoreductive chemotherapy and/or radiotherapy to high-risk sites of bulky disease. All patients then receive conditioning therapy comprising fludarabine IV on days -4 to -2. Patients undergo low-dose total body irradiation followed by unmodified allogeneic peripheral blood stem cell or bone marrow transplantation on day 0. Patients receive oral mycophenolate mofetil (MMF) daily on days 0-27. Regimen A - Chronic lymphocytic leukemia, chronic myelogenous leukemia (CML) in first chronic phase - Acute myeloid leukemia (AML) in first complete remission (CR) - Refractory anemia with ringed sideroblasts (RARS) - Myeloma in CR or partial remission (PR) - Low-grade non-Hodgkin's lymphoma (NHL) - Aggressive NHL in first CR Patients receive oral cyclosporine twice daily beginning on day -3. If there is no evidence of graft-versus-host disease (GVHD), cyclosporine is tapered from day 56 until discontinuation by day 180. Beginning at least 2 weeks after completion of cyclosporine, patients with progressive disease receive donor lymphocyte infusion (DLI) IV over 30 minutes for up to 3 infusions. Patients with stable disease may receive DLI at 9-12 months post-transplantation. Regimen B - CML in accelerated phase or greater than first CR - AML beyond first CR - Myelodysplastic syndrome other than RARS - Myeloma not in CR/PR - Other NHL Patients receive oral cyclosporine twice daily beginning on day -3. If there is no evidence of GVHD, cyclosporine is tapered from day 56 until discontinuation by day 77. Beginning at least 2 weeks after the completion of cyclosporine, patients with persistent disease receive DLI IV over 30 minutes for up to 3 infusions. Patients are followed at day 84, months 4, 6, 12, 18, and 24, and then annually thereafter. PROJECTED ACCRUAL: A total of 160 patients (80 per risk group) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Over 49 and under 75 years of age with diagnosis of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), or multiple myeloma - Ineligible for curative autologous peripheral blood stem cell (PBSC) or bone marrow transplantation (BMT) OR - Failed prior autologous PBSC or BMT - NHL and CLL patients: - Failed prior therapy with an alkylating agent and/or fludarabine OR - At high risk of relapse - Multiple myeloma patients: - Stage II or III disease - Prior chemotherapy required OR - Under 50 years of age with diagnosis of NHL, Hodgkin's lymphoma, CLL, or multiple myeloma - High risk of regimen-related toxicity due to prior autologous PBSC or BMT or pre-existing medical conditions OR - Under 75 years of age with diagnosis of other malignant disease amenable to treatment with allogeneic BMT - High risk for regimen-related toxicity with standard high-dose regimens due to pre-existing chronic disease of the kidneys, liver, lungs, or heart - Including, but not limited to, the following diseases: - Myelodysplastic syndromes - Myeloproliferative syndromes - Acute leukemia with less than 10% blasts in bone marrow - Amyloidosis - Hodgkin's lymphoma - Ineligible for high-priority curative autologous PBSC or BMT - No rapidly progressive aggressive NHL unless in minimal disease state - No CNS involvement - Must have genotypically or phenotypically HLA identical related donor that meets all of the following criteria: - 12 to 74 years of age - Not an identical twin - Not pregnant - HIV negative - No know allergy to filgrastim (G-CSF) - No concurrent serious systemic illness PATIENT CHARACTERISTICS: Age: - Under 75 Performance status: - Karnofsky 50-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGPT and SGOT no greater than 4 times ULN Renal: - Renal failure allowed - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No poorly controlled hypertension (blood pressure 150/90 or greater while receiving standard medication) - Ejection fraction at least 40% Pulmonary: - No supplementary continuous oxygen - DLCO at least 30% - Total lung capacity (TLC) at least 30% - FEV_1 at least 30% Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 12 months after study - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent growth factors on days 0-27 Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidMaloney, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Stanford University Medical Center
Stanford, California, 94305-5623
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
Universitaet Leipzig
Leipzig, , D-04103
Germany
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239
United States
Stanford University
Stanford, California, 94305
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
United States
University of Torino
Torino, , 10126
Italy
Additional Information:
Study ID Numbers: CDR0000068521; FHCRC-1596.00,NCI-H01-0068
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014235
Other Hematopoietic And Lymphoid Cancer Studies:
1. Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia
2. Monoclonal Antibody Therapy After Allogeneic Stem Cell Transplantation in Treating Patients With Persistent or Progressive Cancer
3. Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
4. Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
5. Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
Related Studies:
Other hematopoietic and lymphoid cancer Clinical Trials
Other Clinical Trials
Other Torino Clinical Trials
Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer
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