NCT00278382

Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (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 blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma

Detailed description

PRIMARY OBJECTIVES: I. Determine the overall response rate, including complete and partial responses, in patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with sorafenib. SECONDARY OBJECTIVES: I. Determine progression-free and overall survival of patients treated with this drug. II. Determine response duration in patients treated with this drug. OUTLINE: This is an open-label study. Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Conditions

• Anaplastic Large Cell Lymphoma
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-12-01
• First posted: 2006-01-18
• Last updated: 2013-02-07

Locations

1 site across 1 country: United States