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Sponsored by: |
Fox Chase Cancer Center CCOP Research Base |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002809 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Drug: methotrexate Drug: sargramostim Drug: tacrolimus Drug: therapeutic immune globulin Procedure: allogeneic bone marrow transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States |
Estimated Enrollment: | 10 |
Study Start Date: | August 1996 |
OBJECTIVES:
OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure.
All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin.
Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5 years.
Ages Eligible for Study: | 17 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following hematologic malignancies/disorders:
Acute lymphoblastic leukemia
Acute myelogenous leukemia (AML)
In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7
Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase
Myelodysplastic syndrome, i.e.:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Pennsylvania | |
Fox Chase-Temple Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2442 |
Study Chair: | Kenneth F. Mangan, MD, FACP | Fox Chase Cancer Center CCOP Research Base |
Study ID Numbers: | CDR0000064937, TUHSC-2803, NCI-V96-0950 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002809 |
Health Authority: | United States: Federal Government |
recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission refractory anemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
secondary acute myeloid leukemia previously treated myelodysplastic syndromes atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
Leukemia, Lymphoid Chronic myelogenous leukemia Hematologic Neoplasms Precancerous Conditions Refractory anemia Tacrolimus Cyclophosphamide Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Preleukemia Anemia, Refractory Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis |
Rho(D) Immune Globulin Methotrexate Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Immunoglobulins Chronic lymphocytic leukemia Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Pathologic Processes Therapeutic Uses Syndrome Abortifacient Agents Alkylating Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |