Leukemia

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia

  • Relapsed* or refractory disease NOTE: *Remission must have lasted < 1 year

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 50 mL/min
• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST/ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk for undergoing study treatment
• No other concurrent severe disease
• No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment
• No concurrent significant disease, illness, or psychiatric disorder that would compromise patient safety or compliance or that would interfere with informed consent, study participation, follow-up, or interpretation of study results

• No diagnosis of another malignancy, unless the patient has been disease-free for ≥ 3 years following the completion of curative intent therapy

  • Patients with nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia are eligible (regardless of disease-free duration) provided definitive treatment for the condition has been completed
  • Patients with organ-confined prostate cancer are eligible provided there is no evidence of recurrent or progressive disease based on PSA values AND hormonal therapy has been initiated or a radical prostatectomy or definitive radiotherapy has been performed
• No currently active gastrointestinal disease that may affect the ability of the patient to absorb oral clofarabine

PRIOR CONCURRENT THERAPY:

• Recovered from all prior therapy
• More than 30 days since prior and no other concurrent investigational agents
• More than 2 weeks since prior anticancer therapy, except hydroxyurea
• No prior cytarabine or clofarabine
• No prior surgery that may affect the ability of the patient to absorb oral clofarabine
• No concurrent alternative medications (e.g., herbal or botanical medications for anticancer purposes)
• No other concurrent chemotherapy, radiotherapy, or immunotherapy
• No other concurrent cytotoxic therapy