VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia

Inclusion Criteria

• •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