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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Ultraviolet A Light Therapy With Methoxsalen (PUVA) With or Without Bexarotene in Patients With Mycosis Fungoides

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Over 18	Other	EORTC-21011 NCT00056056

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 19 years old
• At least 3 months since interferon therapy or topical chemotherapy
• No previous systemic combination chemotherapy,
• No previous participation in a clinical trial using bexarotene
• At least 1 month since topical corticosteroids, ultraviolet light therapy, retinoid drugs, beta-carotene drugs, or other topical medications
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive methoxsalen by mouth followed 2 hours later with whole-body ultraviolet light therapy. Treatment will be repeated three times a week. Patients in group two will receive bexarotene by mouth once a day followed by treatment as in group one. Treatment may continue for up to 16 weeks. Patients will be evaluated every 8 weeks for as long as benefit is shown.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Sean Whittaker, MD, Study coordinator		Ph: 44-20-7188-6396

Austria
	Graz
	Karl-Franzens-University Graz
		Contact Person	Ph:  43-316-380-4100
	Vienna
	Allgemeines Krankenhaus - Universitatskliniken
		Contact Person	Ph:  43-1-40-400
Belgium
	Gent
	Ghent University
		Contact Person	Ph:  32-9-264-3033
	Leuven
	U.Z. Gasthuisberg
		Contact Person	Ph:  32-16-34-3322-11
Denmark
	Copenhagen
	Bispebjerg Hospital
		Contact Person	Ph:  45-3531-3531
Finland
	Helsinki
	Helsinki University Central Hospital
		Contact Person	Ph:  358-9-4711
France
	Creteil
	Centre Hospitalier Universitaire Henri Mondor
		Contact Person	Ph:  33-1-49-812-590
	Nantes
	CHR Hotel Dieu
		Contact Person	Ph:  33-2-40-083-271
Germany
	Mannheim
	Klinikum der Stadt Mannheim
		Contact Person	Ph:  49-621-383-3833
	Minden
	Klinikum Minden
		Contact Person	Ph:  49-571-801-4810
	Tuebingen
	Hospital Universitario Insular de Gran Canaria
		Contact Person	Ph:  34-92-844-4000
	Southwest German Cancer Center at Eberhard-Karls-University
		Contact Person	Ph:  49-7071-292-711
	Wuerzburg
	Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
		Contact Person	Ph:  49-931-201-700-00
Hungary
	Budapest
	Semmelweis University
		Contact Person	Ph:  36-1-317-0891
	Kaposvar
	County Hospital
		Contact Person	Ph:  36-82-501-300
Israel
	Petah-Tikva
	Rabin Medical Center - Beilinson Campus
		Contact Person	Ph:  972-3-937-7377
Italy
	Brescia
	Spedali Civili di Brescia
		Contact Person	Ph:  39-030-395-823
	Rome
	Istituto Dermopatico Dell' Immacolata
		Contact Person
	Turin
	Universita di Torino
		Contact Person	Ph:  39-011-670-5955
Netherlands
	Leiden
	Leiden University Medical Center
		Contact Person	Ph:  31-71-526-9111
Spain
	Barcelona
	Hospital Clinic de Barcelona
		Contact Person	Ph:  34-93-227-5400 ext. 2262
	Hospital de la Santa Cruz i Sant Pau
		Contact Person	Ph:  34-3-291-91-25
	Hospital Universitari de Bellvitge
		Contact Person	Ph:  34-93-260-7812
	Madrid
	Hospital Universitario 12 de Octubre
		Contact Person	Ph:  34-91-741-7780
	Santa Cruz de Tenerife
	Hospital Universitario Nuestra Senora de la Candelaria
		Contact Person	Ph:  34-922-602-170
Switzerland
	Zurich
	UniversitaetsSpital Zuerich
		Contact Person	Ph:  41-1-255-1111
United Kingdom
England
	London
	St. Thomas' Hospital
		Contact Person	Ph:  44-20-792-892-92 ext. 1333
Scotland
	Edinburgh
	Royal Infirmary of Edinburgh at Little France
		Contact Person	Ph:  44-131-536-1000

Registry Information
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
Trial Start Date		2003-01-20
Registered in ClinicalTrials.gov		NCT00056056
Date Submitted to PDQ		2003-01-30
Information Last Verified		2009-07-21

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