NCT00056056

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	bexarotene	The recommended initial dosage of Bexarotene (75 mg Bexarotene capsules to be administered according to body surface area) for patients entered in this trial is 300 mg/m2 /once a day, taken orally, till CCR, PD, unacceptable toxicity, 16 weeks of treatment, whichever comes first
DRUG	methoxypsoralen	The dose of methoxypsoralen, as conventional capsules or liquid-filled capsules, is based on the patient's weight. The standard dose of 0.6 mg/kg will be given to all patients three times weekly - Increasing dose of PUVA according to a set protocol after a Minimal Phototoxic Dose (MPD) testing.
PROCEDURE	UV light therapy	Initial UVA light exposure times should be based on the minimal phototoxic dose (MPD) for the specific light source being used. MPD can be determined by irradiating several skin areas 2 cm in diameter with varying light exposure times and determining the exposure time that produces erythema at 72 hours. The initial dose of UVA administered will be 70% of the MPD. The dose of UVA for the subsequent UVA sessions will be increased according to a standard protocol consisting of 20% increments with each successive treatment session depending on the presence of erythema.

Timeline

• Start date: 2003-01-01
• Primary completion: 2010-05-01
• Completion: 2011-06-01
• First posted: 2003-03-07
• Last updated: 2018-07-09

Locations

28 sites across 13 countries: Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom