Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides

Lymphoma Clinical Trial

Official title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides

Status Terminated

Clinical Trial Summary

RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.

Clinical Trial Description

OBJECTIVES:

• Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene yields a significantly higher overall response rate in patients with mycosis fungoides.

• Compare the overall response rate (CCR and partial response) in patients treated with these regimens.

• Compare the duration of CCR and time to relapse of patients treated with these regimens.

• Compare the number of PUVA sessions necessary to achieve a CCR in these patients.

• Determine the percentage of dropouts by patients treated with these regimens.

• Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and stage of disease (IB vs IIA). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week.

• Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity.

Patients are followed every 8 weeks until the first documented progression or relapse.

PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 25 months. ;

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides

• NCT number: NCT00056056
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Terminated
• Phase: Phase 3
• Start date: January 2003
• Completion date: June 2011