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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062140 |
Purpose
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 Radiation: 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000304522, FHCRC-1797.00 |
| Study First Received: | June 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062140 History of Changes |
| 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 |
|
Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome Lymphoma, Large-Cell, Immunoblastic Alkylating Agents Lymphoma Neoplasms by Histologic Type |
Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Myelodysplastic-Myeloproliferative Diseases |