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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303719 |
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor stem cell transplant for hematologic cancer, metastatic breast cancer, or kidney cancer.
Condition | Intervention |
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Breast Cancer Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy |
Estimated Enrollment: | 150 |
Study Start Date: | March 2002 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to risk (standard vs high).
Preparative regimen: Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine IV over 1 hour on days -6 to -2. Patients undergo total body irradiation on day -1. Some patients also receive anti-thymocyte globulin (ATG)* IV every 12 hours on days -6 to -4. Patients who receive ATG* include the following:
Patients also receive mycophenolate mofetil IV or orally twice daily on days -3 to 30.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Ages Eligible for Study: | up to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Acute myeloid leukemia (AML), meeting the following criteria:
High-risk disease, as evidenced by 1 of the following criteria:
Must be in remission by morphology
Ineligible if in morphologic relapse/persistent disease, defined as > 5% blasts in normocellular bone marrow OR any percentage of blasts if blasts have unique morphologic markers (e.g., auer rods) or associated cytogenetic markers that allow morphologic relapse to be distinguished
Acute lymphocytic leukemia (ALL), meeting the following criteria:
High-risk disease, as evidenced by 1 of the following criteria:
Must be in remission by morphology
Ineligible if in morphologic relapse/persistent disease, defined as > 5% blasts in normocellular bone marrow OR any percentage of blasts if blasts have unique morphologic markers or associated cytogenetic markers that allow morphologic relapse to be distinguished
Chronic myelogenous leukemia (CML)
Non-Hodgkin's lymphoma (NHL)
Hodgkin's lymphoma
MDS of all subtypes including refractory anemia if severe pancytopenia or high-risk cytogenetics
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | Marcie Tomblyn, MD, MS | Masonic Cancer Center, University of Minnesota |
Principal Investigator: | Daniel J. Weisdorf, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000450876, UMN-2001LS058, UMN-MT2001-10 |
Study First Received: | March 15, 2006 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00303719 History of Changes |
Health Authority: | Unspecified |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities refractory multiple myeloma adult acute myeloid leukemia with inv(16)(p13;q22) recurrent adult Hodgkin lymphoma adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) Burkitt lymphoma stage III childhood Hodgkin lymphoma refractory chronic lymphocytic leukemia stage IV childhood Hodgkin lymphoma stage III chronic lymphocytic leukemia noncontiguous stage II small lymphocytic lymphoma recurrent renal cell cancer refractory anemia with excess blasts in transformation |
refractory anemia with ringed sideroblasts refractory anemia childhood acute lymphoblastic leukemia in remission noncontiguous stage II mantle cell lymphoma recurrent mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma chronic eosinophilic leukemia male breast cancer noncontiguous stage II marginal zone lymphoma adult acute myeloid leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia |
Cyclosporine Mycophenolic Acid Urogenital Neoplasms Mantle Cell Lymphoma Cyclosporins Refractory Anemia Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Kidney Diseases Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders |
Breast Neoplasms Leukemia, Myeloid Carcinoma Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Precancerous Conditions Immunologic Factors Blood Protein Disorders Lymphoma, Follicular Lymphoblastic Lymphoma Lymphoma, B-Cell Anti-Bacterial Agents |
Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Mycophenolic Acid Urogenital Neoplasms Urologic Neoplasms Cyclosporins Preleukemia Neoplasms by Site Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Mycophenolate mofetil |
Cardiovascular Diseases Kidney Diseases Dermatologic Agents Breast Diseases Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Breast Neoplasms Carcinoma Multiple Myeloma Neoplasms Fludarabine Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial |