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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006042 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
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Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide |
Study Start Date: | December 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of cyclophosphamide.
Patients receive fludarabine IV over 1 hour on days -6 to -2; cyclophosphamide IV over 1 hour on days -6, -5, and 3; total body irradiation on day -1; and allogeneic bone marrow transplantation on day 0. Patients also receive tacrolimus IV or orally twice a day on days 4-50; oral mycophenolate mofetil on days 4-35; and filgrastim (G-CSF) subcutaneously or IV starting on day 4 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined.
Patients are followed at 2 and 6 months, at one year, and then annually thereafter.
PROJECTED ACCRUAL: At least 23 patients will be accrued for this study.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients with any of the following diagnoses:
Chronic myelogenous leukemia
Chronic phase 1
Acute leukemia
Standard risk
High risk
Acute lymphocytic leukemia
Myelodysplastic syndrome
Chronic lymphocytic leukemia
Multiple myeloma
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, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Study Chair: | Ephraim J. Fuchs, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068057, JHOC-J9966, JHOC-99110501, NCI-G00-1816 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006042 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma Burkitt lymphoma refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission |
recurrent/refractory childhood Hodgkin lymphoma stage II adult lymphoblastic lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Tacrolimus Follicular Lymphoma Preleukemia Acute Myelocytic Leukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma B-cell Lymphomas Fludarabine Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Antimetabolites Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Immunologic Factors |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Tacrolimus Cyclophosphamide Hemostatic Disorders Leukemia Preleukemia Pathologic Processes |
Hemorrhagic Disorders Therapeutic Uses Syndrome Lymphoma, Large-Cell, Immunoblastic Mycophenolate mofetil Cardiovascular Diseases Alkylating Agents Lymphoma Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders |