Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

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