NCT00045695

Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.

Detailed description

OBJECTIVES: * Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia. * Determine the toxicity of this drug in these patients. * Determine the time to progression, stable disease duration, and response duration in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib	PS-341 bolus intravenous injection twice weekly\* for 2 out of every 3 weeks

Timeline

• Start date: 2002-08-01
• Primary completion: 2006-03-01
• Completion: 2009-12-01
• First posted: 2003-01-27
• Last updated: 2013-05-17

Locations

12 sites across 2 countries: United States, Canada