Sorafenib and Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute myeloid leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes Read More

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

  • Acute myeloid leukemia (AML) by FAB criteria (By morphology and routine histochemistry and confirmed, when possible, by flow cytometric analysis of surface immunophenotype; co-expression of lymphoid markers permitted)
  • High-risk myelodysplastic syndromes defined as IPSS category of intermediate-2 or greater
• Must be considered unsuitable for intensive chemotherapy regimens
• No documented CNS involvement

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• AST and ALT ≤ 2 times upper limit of normal (ULN)
• Bilirubin normal
• Creatinine ≤ 1.2 times ULN OR creatinine clearance ≥ 50 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
• No upper gastrointestinal or other conditions that would preclude compliance with or administration of oral medication

• No serious illness or medical condition that would not permit the patient to be managed according to the protocol, including any of the following:

  • History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent
  • Active, uncontrolled, serious infections
  • Active peptic ulcer disease
  • Evidence of bleeding diathesis
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No active cardiomyopathy or unstable ventricular arrhythmia
• No poorly controlled hypertension (e.g., systolic BP ≥ 150 mm Hg or diastolic BP ≥ 95 mm Hg)
• No known hypersensitivity to the study drugs or their components
• No preexisting hypothyroidism prior to enrollment unless patient is euthyroid on medication
• No neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• At least 2 days since prior hydroxyurea
• No other prior chemotherapy

• No concurrent therapeutic doses (≥ 2 mg/day) of anticoagulants (e.g., warfarin)

  • Doses of up to 2 mg/day given for prophylaxis of thrombosis are accepted provided INR is ≤ 1.5
• No other concurrent experimental drugs or anticancer therapy