Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

DISEASE CHARACTERISTICS:

• Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia

• International Prognostic Scoring System (IPSS) score ≥ intermediate-1

  • Low IPSS score allowed provided patient meets ≥ 1 of the following criteria:

    • Platelet count ≤ 50,000/mm^3
    • Required platelet or packed red cell transfusions within the past 4 weeks
    • Neutropenic (i.e., absolute neutrophil count < 1,000/mm^3) AND has infections requiring antibiotic treatment
• No prior leukemia or refractory anemia with excess blasts in transformation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Baseline QTc < 500 msec
• QTc interval < 460 msec with potassium > 4.0 mEq/L and magnesium > 1.8 mg/L

Immunologic

• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
• No ongoing or active infection
• HIV negative

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• No other malignancy within the past 12 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior administration of any of the following:

  • Interferon
  • Filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or other hematopoietic cytokines
  • Thalidomide or thalidomide analogs
• No concurrent epoetin alfa

Chemotherapy

• More than 4 weeks since prior chemotherapy
• No prior arsenic trioxide or azacitidine
• No other concurrent chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

• No concurrent androgenic steroids

  • Concurrent steroids for adrenal failure or as prophylaxis for nausea allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 4 weeks since prior retinoids
• No other concurrent investigational agents
• No other concurrent anticancer therapy