Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

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

Objectives

1. Compare the cumulative dose of ultraviolet A light required to achieve a complete clinical response (CCR) in patients with mycosis fungoides treated with ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene.
2. Compare the overall response rate (CCR and partial response) in patients treated with these regimens.
3. Compare the duration of CCR and time to relapse of patients treated with these regimens.
4. Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
5. Determine the percentage of dropouts by patients treated with these regimens.
6. Determine the safety of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed mycosis fungoides
  • Stage IB or IIA
  • Confirmed by current or prior diagnostic lesion biopsy

Prior/Concurrent Therapy:

Biologic therapy

• At least 3 months since prior interferon therapy

Chemotherapy

• No prior systemic combination chemotherapy
• No prior participation in another study of bexarotene
• At least 3 months since prior topical chemotherapy

Endocrine therapy

• At least 1 month since prior topical corticosteroids

Radiotherapy

• At least 6 months since prior total skin electron beam therapy
• At least 1 month since prior superficial radiotherapy

Surgery

• Not specified

Other

• At least 30 days since prior participation in another investigational drug study
• At least 3 months since prior photopheresis
• At least 1 month since prior UVB/PUVA phototherapy
• At least 1 month since prior retinoid class drugs
• At least 1 month since prior beta-carotene compounds
• At least 1 month since other prior topical medications (e.g., tar baths)
• No prior participation in this study
• No other concurrent anticancer therapy
• No other concurrent investigational drug therapy
• No concurrent drugs associated with pancreatic toxicity or known to increase triglyceride concentrations

Patient Characteristics:

Age

• Over 18

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN

Renal

• Creatinine no greater than 2 times ULN
• Calcium no greater than 11.5 mg/dL

Cardiovascular

• No New York Heart Association grade III or IV cardiac insufficiency

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study participation*

   [Note: *Women using hormonal contraception must also use a non-hormonal treatment]

• Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization)
• Willing and able to avoid prolonged exposure to the sun
  • Willing to limit sun exposure on day of PUVA therapy
• No prior intolerance of or unresponsiveness to PUVA therapy
• No other prior or concurrent malignant tumor except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• No prior pancreatitis
• No other concurrent serious illness or infection that would preclude study participation
• No concurrent excessive alcohol consumption
• No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive drugs) factors
• No psychological, familial, sociological, or geographical condition that would preclude study compliance
• No known contraindications to study drug
• No known hypersensitivity to retinoids or hypervitaminosis A
• No uncontrolled diabetes mellitus
• No uncontrolled thyroid disease

Expected Enrollment

A total of 134 patients (67 per treatment arm) will be accrued for this study within 17 months.

Outcomes

Cumulative dose of UVA necessary to achieve a complete clinical response (CCR) by Tumor Burden Index and appearance or disappearance of extracutaneous lesions every 4 weeks during treatment and then every 8 weeks until progression

Overall response rate (CCR + partial response [PR]) by Tumor Burden Index and appear. or disappear. of extracutaneous lesions every 4 weeks during treatment and then every 8 weeks until progression
Time to relapse as measured by Logrank every 4 weeks during treatment, then every 8 weeks
Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression
Number of UVA light therapy with methoxsalen (PUVA) sessions necessary to achieve a CCR by median and range at the completion of treatment
Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks
Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment

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.

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
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		2008-04-13

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