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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004181 |
Purpose
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia, or agnogenic myeloid metaplasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Multiple Myeloma and Plasma Cell Neoplasm |
Drug: busulfan Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma |
| Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: Patients are stratified by remission (first vs second vs third).
Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1. Allogeneic bone marrow is infused on day 0.
Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2. Allogeneic bone marrow is infused on day 0.
Patients are followed at days 30 and 90, at 6 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 15 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm^3):
Chronic myelogenous leukemia in first or second chronic phase
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Martin S. Tallman, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000067417, NU-92H3T, NCI-G99-1639 |
| Study First Received: | January 21, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004181 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
chronic phase chronic myelogenous leukemia chronic idiopathic myelofibrosis Philadelphia chromosome positive chronic myelogenous leukemia |
|
Philadelphia Chromosome Immunologic Factors Blood Protein Disorders Paraproteinemias Leukemia, Myeloid, Chronic-Phase Cyclophosphamide Hemostatic Disorders Leukemia Hemorrhagic Disorders Metaplasia Chronic Myeloproliferative Disorders Alkylating Agents Myelofibrosis Immunoproliferative Disorders Hematologic Diseases |
Blood Coagulation Disorders Myeloproliferative Disorders Vascular Diseases Leukemia, Myeloid Immunosuppressive Agents Multiple Myeloma Myeloid Metaplasia Lymphatic Diseases Busulfan Leukemia, Myelogenous, Chronic, BCR-ABL Positive Antineoplastic Agents, Alkylating Chronic Myelogenous Leukemia Antirheumatic Agents Bone Marrow Diseases Lymphoproliferative Disorders |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Leukemia, Myeloid, Chronic-Phase Cyclophosphamide Hemostatic Disorders Leukemia Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Myelofibrosis |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Vascular Diseases Leukemia, Myeloid Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Myeloid Metaplasia Lymphatic Diseases Neoplasms Myeloablative Agonists Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
