Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia

OBJECTIVES: Primary * Compare the complete response (CR) and CR (with platelet count \< 100,000/mm\^3 but ≥ 20,000/mm\^3 \[transfusion independent for ≥ 7 consecutive days\]) (CRp) rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M. Secondary * Compare time to progression in patients treated with these regimens. * Compare duration of response in patients treated with these regimens. * Compare the survival of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. Patients are stratified according to age (\< 60 years vs ≥ 60 years) and duration of first complete response (CR) or CR (with platelet count \< 100,000/mm³ but ≥ 20,000/mm³ \[transfusion independent for ≥ 7 consecutive days\]) (CRp) (\< 12 months vs ≥ 12 months). * Induction therapy: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). * Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine). In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based on total cellularity and percent blasts) after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy. * Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp, patients receive 1 course of consolidation therapy, as per induction therapy, according to their randomized treatment arm. These patients may then proceed to other consolidation, maintenance, and/or intensification therapy (including stem cell transplantation) off study at the discretion of the physician. After completion of study treatment, patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued for this study within 24-30 months.