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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062140 |
RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy |
Study Start Date: | April 2003 |
OBJECTIVES:
OUTLINE:
Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices.
Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of hematological malignancy, including any of the following:
Availability of 1 of the following types of allogeneic donors:
Unrelated donors
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | George B. McDonald, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000304522, FHCRC-1797.00 |
Study First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062140 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult Burkitt lymphoma |
noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Mycoses Preleukemia Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Acute myeloid leukemia, adult Hodgkin Disease Chronic lymphocytic leukemia Myelodysplastic syndromes |
Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Leukemia, Lymphoid |
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Pathologic Processes Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |