Clinical Trials Directory

Trials / Terminated

TerminatedNCT00303966

Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

A Phase II Study of BAY 43-9006 in Relapsed Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
5 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGsorafenib tosylateGiven orally

Timeline

Start date
2005-11-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2006-03-17
Last updated
2014-05-07
Results posted
2014-04-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00303966. Inclusion in this directory is not an endorsement.