Conditions: B-cell Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess the response rate (complete response \[CR\] and partial response) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with sunitinib malate.

II. Assess the toxicity of this drug in these patients. III. Assess duration of response, time to progression, overall survival, and CR rate in patients treated with this drug.

SECONDARY OBJECTIVES:

I. Evaluate if known risk stratification parameters (i.e., immunoglobulin mutational status, ZAP-70 status, fluorescent in situ hybridization \[FISH\] defects, and/or CD38 status) are related to clinical response to sunitinib malate.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically for translational and pharmacological studies, including IgVH gene mutation status and ZAP-70 status. Samples are examined by fluorescent in situ hybridization (FISH) and other assays.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

Arms:
arm 1: Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: sunitinib malate intervention 2: pharmacological study intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies

Protocol document: