Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00392496|
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : December 12, 2013
Last Update Posted : May 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma||Drug: sunitinib malate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Arm I
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.
Drug: sunitinib malate
- Objective Tumor Response [ Time Frame: Up to 3 years ]It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma and reviewed independently
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392496
|National Cancer Institute of Canada Clinical Trials Group|
|Kingston, Ontario, Canada, K7L 3N6|
|Principal Investigator:||Rena Buckstein||Canadian Cancer Trials Group|