Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

DISEASE CHARACTERISTICS:

Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:

Refractory disease, defined as persistent or progressive disease after ≥ 2 induction regimens, including ≥ 1 course of high-dose cytarabine (ARA-C)
Relapsed disease that has recurred within 1 year of an ARA-C-containing chemotherapy regimen

No CNS disease requiring radiotherapy

Patients with neurological symptoms must undergo a lumbar puncture and a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
ALT and AST ≤ 2.0 times the ULN
Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min

INR ≤ 1.5 and aPTT within ULN

Patients receiving anticoagulation therapy (e.g., warfarin or heparin) are eligible provided anticoagulation therapy can be discontinued or changed to parenteral medications while the platelet count is less than 50,000/mm³
Negative pregnancy test
Fertile patients must use effective contraception
No concurrent active second primary malignancy (excluding superficial, non-invasive skin cancers)
No active bleeding diathesis, not including closely monitored therapeutic anticoagulation

No cardiac disease, including any of the following:

New York Heart Association class II-IV congestive heart failure
Unstable angina (i.e., anginal symptoms at rest)
New onset angina (i.e., began within the past 3 months)
Myocardial infarction within the past 6 months
No active clinically serious infection > grade 2
No cerebrovascular accident, including transient ischemic attacks, within the past 6 months
No pulmonary hemorrhage ≥ grade 2 within the past 4 weeks
No other hemorrhage or bleeding event ≥ grade 3 within the past 4 weeks
No known HIV infection or chronic hepatitis B or C
No serious non-healing wound or ulcer
More than 4 weeks since prior significant traumatic injury
No prior history of sinusoidal obstructive syndrome (veno-occlusive disease)

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior major surgery or open biopsy
More than 100 days since any prior hematopoietic stem cell transplant

No concurrent treatment with any other investigational agent for AML

Intrathecal chemotherapy administration is allow for central nervous system leukemic infiltration
No prior allogeneic stem cell transplant within the past 100 days, with active graft-versus-host disease (GVHD) of any grade, or exposure to immynosuppression for GVHD or prophylaxis