VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid Leukemia

DISEASE CHARACTERISTICS:

Histologically confirmed de novo acute myeloid leukemia (AML)

No acute promyelocytic leukemia [t(15;17)]
No favorable cytogenetics, including t(15;17), t(8;21), or inv 16
No secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS] or myeloproliferative disease), or history of prior chemotherapy or radiation for a disease other than AML

Must have ≥ 1 of the following poor-risk features:

Any of the following unfavorable cytogenetics:

Del (5q)/-5q
-7/del(7q)
Abnormal 3q, 9q, 11q, 20q, 21q, or 17p
t(6;9)
t(9;22)
Trisomy 8
Complex karyotypes (≥ 3 unrelated abnormalities)
At least 70 years of age
ECOG performance status (PS) of 2

Cardiac dysfunction* that would limit the use of anthracycline therapy, as defined by any of the following:

Ejection fraction ≤ 50%
History of significant coronary artery disease, defined as ≥ 1 vessel stenosis requiring medical treatment, stent placement, or surgical bypass graft
History of congestive heart failure or myocardial infarction

Significant arrhythmia, including any of the following:

Atrial flutter (excluding atrial fibrillation)
Sick sinus syndrome
Ventricular arrhythmia

Heart valve disease

Mitral valve prolapse allowed
Other heart disease, at the discretion of the principal investigator

Pulmonary dysfunction not related to AML, defined by 1 of the following:

DLCO and/or FEV_1 < 80% and ≥ 50% normal range
Dyspnea on slight activity or at rest
Requires oxygen
Hepatic dysfunction related to chronic hepatitis or liver cirrhosis
Other organ dysfunction or comorbidity that precludes standard cytotoxic induction treatment (e.g., "3+7"), at the discretion of the principal investigator NOTE: *Patients with a history of heart disease as defined above must be on appropriate medication and have their disease under control
No known CNS disease

PATIENT CHARACTERISTICS:

ECOG PS 0-2
AST and ALT ≤ 5 times upper limit of normal
Bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment

No active, uncontrolled infection

Patients with an infection who are under active treatment with antibiotics and whose infections are controlled are eligible
Chronic hepatitis allowed
No clinical evidence of ongoing second malignancy unrelated to AML or MDS
No evidence of left bundle branch block on screening ECG
No obligate use of cardiac pacemaker or atrial fibrillation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 24 hours since prior metronidazole
No prior low-dose, single-agent, cytotoxic chemotherapy (e.g., cytarabine, decitabine, or azacitidine)
No concurrent disulfiram

No other concurrent standard or investigational therapy for AML except for the following:

Concurrent hydroxyurea to control rising white blood cell counts

Dosage must be 4-6 grams daily for up to 4 days

Concurrent leukapheresis to control blast cell counts

Must be completed within the first 5 days of study therapy
No more than 2 procedures per day or 4 procedures total
Investigational supportive care agents (e.g., antimicrobials or antifungal agents), at the discretion of the protocol sponsor