Sorafenib 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. This phase II trial is studying how well sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with recurrent chronic lymphocytic leukemia (CLL) treated with sorafenib. II. Determine the toxicity in patients treated with sorafenib. SECONDARY OBJECTIVES: I. Correlate bone marrow angiogenesis, CLL tumor cell expression of vascular endothelial growth factor (VEGF), VEGF receptors (flt-1, KDR, flt-4 and neuropilin-1), basic fibroblast growth factor, and plasma interleukin-8 levels with response. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Given orally
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Objective Response Rate
Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with \>50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).
Time frame: Up to week 25
Time to Disease Progression
Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.
Time frame: Up to 5.5 years
Overall Survival
Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.
Time frame: Up to 5.5 years
Changes in Mean Microvessel Density From Baseline to Week 25
Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.
Time frame: Baseline and week 25
Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25
Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.
Time frame: Baseline and week 25
Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25
The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and week 25