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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002831 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
Condition | Intervention | Phase |
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Leukemia |
Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: decitabine Drug: methotrexate Drug: methylprednisolone Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PHASE I/II STUDY OF HIGH-DOSE DEOXYAZACYTIDINE, BUSULFAN, AND CYCLOPHOSPHAMIDE WITH ALLOGENEIC STEM CELL TRANSPLANTATION FOR HEMATOLOGIC MALIGNANCIES |
Estimated Enrollment: | 30 |
Study Start Date: | July 1994 |
OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in combination with busulfan and cyclophosphamide in patients with hematologic malignancies. II. Establish the pharmacokinetics of decitabine and busulfan in this patient population. III. Determine the effectiveness of this combination in achieving durable complete remission in patients with chronic myelogenous leukemia (CML) in blast crisis or acute myelogenous leukemia (AML) in relapse undergoing allogeneic stem cell transplantation.
OUTLINE: In cohorts of 3, patients receive escalating doses of decitabine (DAC) IV over 4 hours on days -8 and
For graft vs host disease prophylaxis (GVHD), patients receive tacrolimus IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus. Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment. All patients receive methylprednisolone given according to clinical grade of GVHD procedures. For CNS prophylaxis, methotrexate is given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment. Allogeneic patients are followed until the end of 1 year.
PROJECTED ACCRUAL: An estimated 30 allogeneic recipients will be recruited in 2 years for the expected study duration of 2-3 years.
Ages Eligible for Study: | 15 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Acute leukemia past first remission or induction failure Chronic myelogenous leukemia in accelerated phase or blast crisis
PATIENT CHARACTERISTICS: Age: 15 to 55 Performance status: Zubrod 0-2 Life expectancy: Life expectancy not severely limited by concurrent illness Hematopoietic: Not specified Hepatic: No evidence of chronic active hepatitis or cirrhosis Bilirubin no greater than 2 times upper limit of normal SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% No uncontrolled arrhythmias or symptomatic cardiac disease Pulmonary: FEV1, FVC, and DLCO at least 50% No symptomatic pulmonary disease Other: Related donor who is HLA-identical required No effusion or ascites greater than 1 L prior to drainage HIV negative Not pregnant No active CNS disease
PRIOR CONCURRENT THERAPY: Not specified
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Sergio Giralt, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000065033, MDA-DM-94064, NCI-G96-0999 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002831 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult acute myeloid leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Blast Crisis Cyclosporine Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Folate Antiemetics Prednisolone acetate Cyclophosphamide Tacrolimus Leukemia, Myeloid, Acute |
Hormones Neuroprotective Agents Cyclosporins Vitamin B9 Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Antifungal Agents Methotrexate Alkylating Agents Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Methylprednisolone acetate Leukemia, Myeloid Decitabine |
Anti-Inflammatory Agents Anti-Infective Agents Cyclosporine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Tacrolimus Cyclosporins Hormones Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Antimetabolites Immunologic Factors Antineoplastic Agents Prednisolone acetate Cyclophosphamide Reproductive Control Agents Neuroprotective Agents Leukemia |