Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma

Phase 2

Completed

• Conditions: Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma
• Interventions: Drug: sunitinib malate

• Registration Number: NCT00392496
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Study Start: 2007-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-04
• Results First Submitted: 2013-10-21
• Results First Submitted QC: 2013-10-21
• Results First Posted: 2013-12-12
• Last Update Submitted: 2014-04-28
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	sunitinib malate	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.

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response	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

Trial Locations

Locations (1)

National Cancer Institute of Canada Clinical Trials Group; 🇨🇦 Kingston, Ontario, Canada