National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Phase III Randomized Study of Ultraviolet A Light Therapy With Methoxsalen (PUVA) With or Without Bexarotene in Patients With Mycosis Fungoides
Last Modified: 8/26/2009     First Published: 2/21/2003  

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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActiveOver 18OtherEORTC-21011
NCT00056056

Objectives

  1. 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.
  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

145

A total of 145 patients will be accrued for this study within 25 months.

Outcomes

Primary Outcome(s)

Overall response rate (complete clinical response [CCR) and partial response [PR])

Secondary Outcome(s)

Cumulative dose of UVA required to achieve CCR
Number of PUVA sessions necessary to achieve a CCR
Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression
Time to relapse
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

Trial Sites

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 1
Date Submitted to PDQ 2003-01-30
Information Last Verified 2009-07-21

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00056056