Refractory Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase II Study of BAY 43-9006 in Relapsed Chronic Lymphocytic Leukemia
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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