Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

Lymphoma Clinical Trial

Official title: Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.

Clinical Trial Description

OBJECTIVES:

• Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa.

• Determine the safety and toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral bexarotene once daily for 8 weeks.

Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity.

Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

• NCT number: NCT00030849
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: October 2001
• Completion date: December 2009