Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria: Chronic phase Less than 15% blasts in peripheral blood or marrow Less than 30% blasts and promyelocytes in peripheral blood or marrow Less than 20% basophils in blood or marrow Platelet count at least 100,000/mm^3 (unless therapy related) No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly Complete hematologic response (CHR) No immature myeloid cells in peripheral blood No increased basophils in peripheral blood WBC less than upper limit of normal (ULN) Platelet count less than ULN No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate Loss of prior major cytogenetic response or failure to achieve major cytogenetic response PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin less than 1.5 times ULN AST or ALT less than 2.5 times ULN Renal Creatinine less than 1.5 times ULN Cardiovascular No New York Heart Association grade III or IV congestive heart failure No untreated symptomatic cardiac ischemia No underlying cardiac arrhythmia, including but not limited to any of the following: Conduction abnormality/atrioventricular heart block Nodal/junctional arrhythmia/dysrhythmia Sinus bradycardia or tachycardia Supraventricular tachycardia Ventricular arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study Electrolyte levels (especially potassium and magnesium) normal (CHR patients) No history of noncompliance that would preclude study participation No other concurrent serious, uncontrolled medical condition No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride, or imatinib mesylate More than 28 days since prior investigational agents No concurrent grapefruit or grapefruit juice
Sites / Locations
- UCLA Department of Medicine, Division of Hematology/Oncology
- H. Lee Moffitt Cancer Center
- OHSU Knight Cancer Institute