Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

DISEASE CHARACTERISTICS: Diagnosis of primary or secondary myelodysplastic syndromes (MDS) Any FAB or WHO criteria cellular type allowed Bone marrow blast count on aspiration or biopsy of 1 of the following: No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities) 11-20% 21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification) Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present No rapid progression towards full-blown AML No blast crisis of chronic myeloid leukemia No t(8;21) alone or in combination with other abnormalities Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline) PATIENT CHARACTERISTICS: Age 60 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) Hepatitis B surface antigen negative Renal Creatinine less than 1.5 times ULN Cardiovascular No severe cardiovascular disease No arrhythmias requiring chronic treatment No congestive heart failure No New York Heart Association class III or IV heart disease No symptomatic ischemic heart disease Other HIV negative No active uncontrolled infection No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the past 2 years No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy More than 6 weeks since prior growth factors for primary MDS No concurrent antiangiogenic drugs (e.g., thalidomide) No concurrent interleukin, interferon, or anti-thymocyte globulin Chemotherapy See Disease Characteristics More than 6 weeks since prior hydroxyurea for primary MDS No other prior chemotherapy for MDS or AML Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed Endocrine therapy No concurrent steroids (except as inhalation therapy) Radiotherapy Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed Surgery Not specified Other More than 6 weeks since prior immunosuppressive agents for primary MDS No concurrent amifostine No concurrent cyclosporine No other concurrent experimental therapies