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

Inclusion Criteria

• •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