• Overall response rate (complete response, partial response, or hematologic improvement) defined by the International Working Group Criteria [ Designated as safety issue: No ]
  

• Duration of response [ Designated as safety issue: No ]
  
• Overall survival and progression-free survival at 6 months and 1 year [ Designated as safety issue: No ]
  
• Time to progression at 6 months and 1 year [ Designated as safety issue: No ]
  
• Toxicity and safety [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• Determine the overall response rate (complete response, partial response, or hematological improvement) in patients with intermediate-2 or high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia treated with sunitinib malate.
• Determine the duration of response in patients treated with this drug.
• Determine the overall survival of patients treated with this drug.
• Determine the progression-free survival of patients treated with this drug.
• Determine the time to disease progression in patients treated with this drug.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then monthly thereafter.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following diseases:

  • Myelodysplastic syndromes (MDS) meeting 1 of the following criteria:

    • Intermediate-2 disease
    • High-risk disease (International Prognostic Scoring System [IPSS] score %u2265 1.5)

  • Chronic myelomonocytic leukemia (CMML)

    • WBC > 12,000/mm^3
    • Intermediate-2 disease with WBC %u2264 12,000/mm³
    • High-risk disease (IPSS score %u2265 1.5) with WBC %u2264 12,000/mm³
• Patients with insufficient or inadequate metaphases for cytogenetic analysis are eligible provided bone marrow blasts are > 10% and/or 2-3 cytopenias are present
• No known brain metastases

PATIENT CHARACTERISTICS:

• Life expectancy > 12 weeks
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Calcium %u2264 3.0 mmol/L
• Bilirubin normal
• AST and ALT %u2264 2.5 times upper limit of normal (ULN)
• Creatinine normal OR creatinine clearance %u2265 60 mL/min

• No history of significant electrocardiogram abnormalities including, but not limited to, the following:

  • Ventricular arrhythmias

    • Ventricular tachycardia
    • Ventricular fibrillation %u2265 3 beats in a row
  • QTc prolongation (i.e., QTc interval %u2265 500 msec)
• No history of allergic reaction to compounds of similar chemical or biological composition to sunitinib malate

• No NYHA class III-IV congestive heart failure

  • Patients with a history of NYHA class II congestive heart failure who are asymptomatic on treatment are eligible
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days

• No serious cardiovascular disease within the past 12 months, including the following:

  • Cerebrovascular accident or transient ischemic attack
  • Myocardial infarction
  • Cardiac arrhythmia
  • Stable or unstable angina
  • Symptomatic congestive heart failure
  • Coronary or peripheral artery bypass graft or stenting
• No pulmonary embolism within the past 12 months
• No uncontrolled hypertension, defined as systolic blood pressure (BP) %u2265 140 mm Hg or diastolic BP %u2265 90 mm Hg

• No condition that impairs the ability to swallow and retain sunitinib malate tablets, including the following:

  • Gastrointestinal tract disease resulting in an inability to take oral medication
  • Requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease
• No serious or nonhealing wound, ulcer, or bone fracture
• No uncontrolled pre-existing thyroid abnormality
• No concurrent uncontrolled illness, including ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior major surgery
• Prior central thoracic radiotherapy that included the heart in the radiotherapy port allowed provided New York Heart Association (NYHA) congestive heart failure %u2264 class II
• Prior anthracycline exposure allowed provided NYHA congestive heart failure %u2264 class II

• No other prior therapy for MDS or CMML except for epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)

  • At least 2 weeks since prior epoetin alfa
  • At least 4 weeks since prior darbepoetin alfa

• No other prior antiangiogenic agents including, but not limited to, the following:

  • Bevacizumab
  • Sorafenib tosylate
  • Pazopanib hydrochloride
  • AZD2171
  • Vatalanib
  • VEGF Trap

• More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including the following:

  • Azole antifungals (e.g., ketoconazole or itraconazole)
  • HIV protease inhibitors (e.g., indinavir sulfate, saquinavir mesylate, ritonavir, atazanavir, or nelfinavir mesylate)
  • Verapamil
  • Clarithromycin
  • Erythromycin
  • Diltiazem hydrochloride
  • Delavirdine

• More than 12 days since prior and no concurrent potent CYP3A4 inducers, including the following:

  • Rifampin
  • Rifabutin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Hypericum perforatum (St. John's wort)
  • Efavirenz
  • Tipranavir
• No concurrent birth control patch, oral birth control pills, depot, or injectable birth control methods

• No concurrent therapeutic coumarin-derivative anticoagulants (e.g., warfarin)

  • Low dose (%u2264 2 mg) warfarin for prophylaxis of thrombosis allowed
  • Low molecular weight heparin allowed provided INR %u2264 1.5

• No concurrent agents with proarrhythmic potential, including the following:

  • Terfenadine
  • Quinidine
  • Procainamide
  • Disopyramide
  • Sotalol
  • Probucol
  • Bepridil
  • Haloperidol
  • Risperidone
  • Indapamide
  • Flecainide acetate
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies