Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Inclusion Criteria

• Diagnosis of 1 of the following:
• Biopsy proven small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
• Peripheral blood lymphocyte count > 5,000/mm^3
• Lymphocytes must consist of small to moderate size lymphocytes, with 5,000/mm^3) and progressive clonal lymphocytosis
• Measurable (i.e., single diameter > 2 cm) and progressive lymphadenopathy
• Disease-related symptoms, including 1 or more of the following:
• Weight loss > 10% within the past 6 months
• Extreme fatigue attributed to CLL/SLL
• Fevers > 100.5^oF for 2 weeks without evidence of infection
• Night sweats without evidence of infection
• Evidence of progressive marrow failure, as manifested by the development of or worsening anemia (hemoglobin 6 cm below left costal margin) or progressives plenomegaly
• No mantle cell lymphoma, as demonstrated by a negative fluorescent in situ hybridization (FISH) analysis fort(11;14)(IgVH/CCND1) on peripheral blood or tissue biopsy
• ECOG performance status 0-2
• Life expectancy ≥ 12 months
• Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
• AST and ALT ≤ 2.5 times ULN
• Bilirubin normal
• Alkaline phosphatase ≤ 3 times ULN
• Platelet count > 30,000/mm^3 (without transfusion)
• Absolute neutrophil count > 1,000/mm^3
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to complete patient diaries alone or with assistance
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No other malignancy except for squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was curatively treated within the past 2 years
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
• No inability to swallow or retain sunitinib malate capsules due to any of the following:
• Gastrointestinal tract disease
• Requirement for IV alimentation
• Prior surgical procedures affecting absorption
• Active peptic ulcer disease
• No pre-existing thyroid abnormality that would make the patient unable to maintain normal thyroid function with medication
• No pulmonary embolism within the past 12 months
• No serious or nonhealing wound, ulcer, or bone fracture
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infections
• Psychiatric illness or social situation that would limit compliance with study requirements
• No cerebrovascular accident or transient ischemic attack within the past 12 months
• No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
• No significant cardiac arrhythmia, including any of the following:
• QTc prolongation (i.e., QTc interval ≥ 500 msec)
• Ventricular tachycardia
• Atrial fibrillation
• Atrial flutter
• Second or third degree heart block
• No cardiac disease within the past 12 months, including any of the following:
• Myocardial infarction
• Cardiac arrhythmia
• Stable/unstable angina
• Symptomatic congestive heart failure
• Coronary/peripheral artery bypass graft or stenting
• No New York Heart Association (NYHA) class III or IV heart failure
• The following patients are eligible provided they have NYHA class II cardiac function on baseline ECHO/MUGA:
• History of NYHA class II heart failure and asymptomatic on treatment
• No prior anthracycline exposure
• No prior central thoracic radiation that included the heart in the radiation port
• See Disease Characteristics
• At least 4 weeks since prior chemotherapy
• At least 4 weeks since prior rituximab or alemtuzumab
• At least 4 weeks since prior major surgery
• At least 4 weeks since prior oral steroids
• No prior treatment with any other antiangiogenic agent, including any of the following:
• Bevacizumab
• Sorafenib
• Pazopanib

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