Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, untreated adult acute myeloid leukemia, secondary acute myeloid leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed de novo or secondary acute myeloid leukemia with ≥ 20% blasts AND at least 1 of the following characteristics*: Auer rods Peroxidase or sudan black positive blasts Chloroacetate esterase-positive or diffusely non-specific esterase-positive blasts Presence of a myeloid immunophenotype by multiparameter flow cytometry, including expression of one or more myeloid markers (CD13, CD33) on blasts NOTE: *Megakaryocytic leukemia can be diagnosed by the detection of platelet antigens (e.g. factor VIII, glycoprotein Ib or IIb/IIIa) using monoclonal antibodies or the presence of ultrastructural platelet peroxidase No acute promyelocytic leukemia No Philadelphia-chromosome positive chronic myeloid leukemia Prior hematologic disorders, including myelodysplastic syndromes, aplastic anemia, paroxysmal nocturnal hemoglobinuria, and myeloproliferative disorders allowed PATIENT CHARACTERISTICS: Age 18 to 59 Performance status Not specified Life expectancy More than 4 weeks Hematopoietic Not specified Hepatic Bilirubin ≤ 2 times normal* SGOT ≤ 2 times normal* Alkaline phosphatase ≤ 2 times normal* NOTE: *Unless abnormalities are directly attributable to leukemia Renal Creatinine ≤ 1.5 times normal* NOTE: *Unless abnormalities are directly attributable to leukemia Cardiovascular Cardiac ejection fraction ≥ 45%* Absolute QT interval ≤ 460 msec with potassium > 4.0 mEq/L and magnesium > 1.8 mg/dL No myocardial infarction within the past 6 months No uncontrolled symptomatic congestive heart failure No angina pectoris No multifocal cardiac arrythmias No other severe cardiovascular disease NOTE: *Unless abnormalities are directly attributable to leukemia Other No serious medical or psychiatric illness that would preclude informed consent or limit survival to < 4 weeks No uncontrolled diabetes mellitus No other concurrent active malignancy No known hypersensitivity to E. coli-derived drug preparations Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for acute leukemia, except hydroxyurea to control white blood cell counts Prior chemotherapy for an antecedent malignancy or other medical condition allowed Endocrine therapy Not specified Radiotherapy Prior radiotherapy for an antecedent malignancy or other medical condition allowed Surgery Not specified
Sites / Locations
- Roswell Park Cancer Institute