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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003960 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: busulfan Drug: cyclophosphamide Drug: methylprednisolone Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated bone marrow transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies |
| Estimated Enrollment: | 36 |
| Study Start Date: | April 1998 |
OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose chemotherapy.
OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and then tapered. Patients are followed every 6 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched, sibling donor for BMT available No current CNS disease No history of more than 2 episodes of active CNS disease
PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients must use effective contraception No concurrent debilitating medical or psychiatric illness that would preclude compliance No prior malignancy except curatively treated skin cancer or carcinoma of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, South Carolina | |
| Center for Cancer Treatment and Research | |
| Columbia, South Carolina, United States, 29203 | |
| Study Chair: | Paul V. O'Donnell, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000067159, JHOC-98032006, JHOC-J9828, NCI-G99-1543 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003960 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma chronic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
acute undifferentiated leukemia secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
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Anti-Inflammatory Agents Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Refractory Anemia Preleukemia Acute Myelocytic Leukemia Hemorrhagic Disorders Anemia, Refractory Acute Myeloid Leukemia, Adult Neoplasm Metastasis Methylprednisolone Hemisuccinate Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Leukemia, Myeloid Glucocorticoids Multiple Myeloma Chronic Myelogenous Leukemia Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Immunologic Factors Blood Protein Disorders Paraproteinemias Prednisolone acetate |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Preleukemia Pathologic Processes Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal |
Immune System Diseases Hematologic Diseases Glucocorticoids Multiple Myeloma Neoplasms Precancerous Conditions Immunologic Factors Blood Protein Disorders Antineoplastic Agents Paraproteinemias Prednisolone acetate Cyclophosphamide Hemostatic Disorders Neuroprotective Agents Leukemia |
