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

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.

Timeline

Start

2003-01

Primary completion

2010-05

Completion

2011-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “poor accrual”

paper The best overall response (CCR + PR) rate was 71% for PUVA alone and 77% for the combination arm (P = 0·57). PMID 22924950 ↗

Publications

• Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. doi: 10.1111/j.1365-2133.2012.11156.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bexarotene	Small molecule	300 mg/m2	Oral
Background	methoxypsoralen	Unknown	0.6 mg/kg	Oral

Indications