Recurrent Adult Diffuse Large Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory diffuse or mediastinal large B-cell 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.
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with relapsed or refractory, diffuse or
mediastinal, large B-cell lymphoma treated with sunitinib malate.
II. Determine the toxicity of this drug in these patients. III. Determine the effects of
this drug on peripheral blood biomarkers, circulating endothelial cells, and their
precursors in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4
weeks for a maximum of 12 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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