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About
RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
Full description
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression.
Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, 20 additional patients receive treatment as in phase I at the MTD of BMS-354825.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: Approximately 50 patients (30 for phase I and 20 for phase II) will be accrued for this study within 12-18 months.
Enrollment
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Inclusion criteria
Diagnosis of Philadelphia chromosome positive, chronic phase chronic myelogenous leukemia (CML) meeting all of the following criteria*:
Less than 15% blasts in peripheral blood and bone marrow
Less than 20% basophils in peripheral blood
Less than 30% blasts and promyelocytes in peripheral blood and bone marrow
Platelet count at least 100,000/mm^3 NOTE: *Patients who previously met the criteria for accelerated phase or blast phase CML, responded to treatment, and currently meet the criteria for chronic phase CML are eligible
Primary or acquired hematologic resistance to imatinib mesylate OR intolerance to imatinib mesylate defined as follows:
Primary hematologic resistance is defined as failure to reach complete hematologic response (CHR) with a dose of 400 mg/day continued for at least 3 months
Acquired hematologic resistance is defined as achieving a CHR, but subsequently developing a rising WBC to at least 10,000/mm^3
Intolerance is defined as having discontinued imatinib mesylate due to nonhematologic toxicity of any grade
18 and over
ECOG 0-1
Life expectancy, At least 6 months.
Hepatic
Renal
Negative pregnancy test
Fertile patients must use effective contraception for 1 month before, during, and 1 month after study participation
More than 14 days since prior interferon
More than 14 days since prior cytarabine
More than 3 days since prior hydroxyurea
More than 28 days since other prior investigational or antineoplastic agents
More than 7 days since prior imatinib mesylate
At least 5 days or 5 half-lives since prior medications that inhibit platelet function, including the following:
Aspirin
Dipyridamole
Epoprostenol
Eptifibatide
Clopidogrel
Cilostazol
Abciximab
Ticlopidine
At least 5 days or 5 half-lives since prior anticoagulants such as warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, enoxaparin)
At least 5 days or 5 half-lives since prior drugs accepted to have a risk of causing torsades de pointes, including the following:
Class IA antiarrhythmic agents (e.g., quinidine, procainamide, or disopyramide)
Class III antiarrhythmic agents (e.g., amiodarone, sotalol, ibutilide, or dofetilide)
Macrolide antibiotics (e.g., erythromycin or clarithromycin)
Antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, or pimozide)
Tricyclic antidepressants
Cisapride
Bepridil
Inapsine
Methadone
Arsenic
Concurrent anagrelide for thrombocytosis due to CML allowed
Exclusion criteria
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Data sourced from clinicaltrials.gov
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