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Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia



Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

For Condition: relapsing chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia,childhood chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with decitabine may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with decitabine in treating patients who have accelerated or blast phasechronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine. - Determine the survival rate of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Determine the effects of this regimen on gene methylation in the leukemic cells of these patients. OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no). Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed chronic myelogenous leukemia - Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization - Accelerated or non-lymphoid blastic phase PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 2 times ULN Renal - Creatinine less than 2.0 mg/dL Cardiovascular - Normal cardiac function - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior decitabine - At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered - Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Prior imatinib mesylate allowed - Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression - No concurrent grapefruit or grapefruit juice
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Jean-PierreIssa,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Hagop  Kantarjian 713-792-7026


Additional Information:
Study ID Numbers:  CDR0000270678;  NCI-5737,MDA-ID-02205
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054431

Other Relapsing Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia

2. Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

3. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

4. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate

5. Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

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