Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed myelodysplastic syndrome (MDS) indicating one of the following:

  • Refractory anemia (RA)
  • Primary refractory leukopenia or thrombocytopenia with MDS morphology
  • RA with excess blasts (RAEB)
  • RA with ringed sideroblasts (RARS)
  • Chronic myelomonocytic leukemia
  • RAEB in transformation

• RA or RARS must have at least one of the following:

  • Absolute neutrophil count less than 1,000/mm^3
  • Untransfused hemoglobin less than 8 g/dL
  • Platelet count less than 20,000/mm^3
  • Anemia
  • Thrombocytopenia requiring transfusion
  • High risk chromosomal abnormalities

• Any stage of MDS allowed including:

  • Previously untreated MDS
  • Refractory MDS allowed if failure to achieve remission following prior intensive chemotherapy of at least 1 month ago

• Relapsed, refractory, or untreated acute myeloid leukemia (AML) with the following:

  • WBC less than 30,000/mm^3
  • Stable for at least 2 weeks
  • Unlikely to require cytotoxic therapy during study

• Untreated AML with poor risk factors for response to standard therapy including:

  • Greater than 60 years old
  • AML occurs in setting of antecedent hematologic disorder
  • High risk chromosomes (e.g., abnormalities of chromosome 5 or 7 or complex cytogenetic abnormalities)
  • Medical conditions that preclude cytotoxic chemotherapy as primary therapy
• Refusal of cytotoxic chemotherapy allowed
• No clinical evidence of CNS leukostasis or CNS leukemia

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics
• Hemoglobin at least 8 g/dL (transfusion allowed)

Hepatic:

• Bilirubin less than 2.0 mg/dL (unless due to hemolysis or Gilbert's disease)

Renal:

• Creatinine less than 2.0 mg/dL

Cardiovascular:

• No disseminated intravascular coagulation

Pulmonary:

• No pulmonary leukostasis

Other:

• No active infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception 2 weeks prior, during and 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy including colony stimulating factors and recovered

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

• At least 3 weeks since prior hormonal therapy and recovered

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• Not specified