OBJECTIVES: * Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia . * Determine the toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified to acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS) patients ≥ 60 years old with no prior treatment vs AML patients any age in first relapse. (AML patients any age in first relapse closed to accrual 06/09/05). Patients receive VNP40101M IV over 30 minutes once on day 1 (course 1). Four to five weeks after the first course, patients undergo bone marrow aspiration and biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a second course of VNP40101M (at the same dose as in course 1). If patients achieve complete response (CR), or partial CR after the first or second course, a consolidation course may be given comprising VNP40101M at a reduced dose. Patients are followed monthly for 6 months, every 2 months for 12 months, and then every 3 months for 18 months . PROJECTED ACCRUAL: A total of 230 patients (100 with acute myelogenous leukemia (AML) or high-risk myelodysplasia and 130 with AML in first relapse) will be accrued for this study.
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Acute myelogenous leukemia (AML), meeting the following criteria: * In first relapse after first treatment-induced complete remission (CR) (closed to accrual as of 06/09/05) * Duration of first CR less than 12 months * No prior treatment for first relapse except hydroxyurea * FAB type M0, M1, M2, M4-7 * No acute promyelocytic leukemia * No prior treatment with a standard induction regimen containing cytotoxic agents\* (for patients 60 years of age or older) * High-risk myelodysplasia, meeting the following criteria: * 60 years of age and over * No prior cytotoxic chemotherapy\* except hydroxyurea * Prior gemtuzumab ozogamicin allowed * High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE: \*Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2.0 mg/dL * ALT or AST ≤ 5 times upper limit of normal * Chronic hepatitis allowed Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No myocardial infarction within the past 3 months * No symptomatic coronary artery disease * No uncontrolled arrhythmias * No uncontrolled congestive heart failure * No other active heart disease Other * No uncontrolled active infection * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment Chemotherapy * See Disease Characteristics * Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Recovered from all prior therapy * At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent * No concurrent disulfiram (Antabuse) * No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts * No other concurrent treatment for leukemia, except hydroxyurea used during study treatment * No other concurrent investigational drugs