NCT00182637

Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma

A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma.

Detailed description

OBJECTIVES: * Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib. * Determine the safety and tolerability of this drug in these patients. OUTLINE: This is an open-label study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib

Timeline

• Start date: 2004-07-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2005-09-16
• Last updated: 2020-08-03
• Results posted: 2016-02-17

Locations

1 site across 1 country: United States