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Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia



Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia

For Condition: childhood chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I/IIpilot trial to study the effectiveness of homoharringtonine in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of homoharringtonine in patients with accelerated phase or blastic phase chronic myelogenous leukemia (CML). - Determine the toxicity profile of this drug in these patients. - Determine the response duration in patients with late chronic phase CML treated with this drug. - Compare the pharmacokinetics of this drug administered as a continuous infusion vs subcutaneously in these patients. OUTLINE: This is a pilot, dose-escalation study. - Remission induction therapy: Patients with accelerated or blastic phase chronic myelogenous leukemia (CML) receive remission induction therapy comprising homoharringtonine IV continuously over 24 hours on day 1 and then subcutaneously (SC) twice daily on days 2-14 for course 1. Subsequent courses of remission induction therapy comprise homoharringtonine SC twice daily on days 1-14. Treatment continues monthly for at least 2 courses. - Maintenance therapy: Patients with complete hematologic remission receive maintenance therapy consisting of homoharringtonine SC twice daily on days 1-7 monthly for 3 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients with accelerated or blastic phase CML receive escalating doses of homoharringtonine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose level at which 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 25-30 patients with late chronic phase CML receives remission induction and maintenance therapy as for accelerated or blastic phase CML at the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Philadelphia (Ph) chromosome-positive blastic phase chronic myelogenous leukemia (CML) - At least 30% blasts in peripheral blood or bone marrow - Ph chromosome-positive accelerated phase CML defined by any of the following: - At least 15% blasts in peripheral blood or bone marrow - At least 30% blasts and promyelocytes - At least 20% peripheral or marrow basophils - Platelet count less than 100,000/mm^3 unrelated to therapy - Extramedullary disease outside liver or spleen - Clonal evolution defined as presence of additional clones other than Ph chromosome - Hemoglobin less than 7 g/dL unrelated to therapy or bleeding - Ph chromosome-positive late chronic phase CML - Failed prior interferon alfa therapy - Failure of only 1 prior chemotherapy regimen allowed - No early chronic phase CML (less than 12 months since diagnosis) - Ineligible for known regimens or protocols of higher efficacy or priority PATIENT CHARACTERISTICS: Age: - 12 and over Performance status: - Zubrod 0-2 Life expectancy: - At least 2 months Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine less than 2.0 mg/dL Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JorgeCortes,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Jorge  Cortes 713-794-5783


Additional Information:
Study ID Numbers:  CDR0000068237;  MDA-ID-99032,NCI-T99-0044,MDA-FDR001783
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006364

Other Relapsing Chronic Myelogenous Leukemia Studies:
1. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia

2. AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate

3. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

4. Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia

5. Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia

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