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Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: March 6, 2003   Last Updated: August 27, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00056056
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: bexarotene
Drug: methoxsalen
Procedure: UV light therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (complete clinical response [CCR) and partial response [PR]) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative dose of UVA required to achieve CCR [ Designated as safety issue: No ]
  • Number of PUVA sessions necessary to achieve a CCR [ Designated as safety issue: No ]
  • Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression [ Designated as safety issue: No ]
  • Time to relapse [ Designated as safety issue: No ]
  • Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks [ Designated as safety issue: Yes ]
  • Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment [ Designated as safety issue: Yes ]

Estimated Enrollment: 145
Study Start Date: January 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed mycosis fungoides

    • Stage IB or IIA
    • Confirmed by current or prior diagnostic lesion biopsy

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 2,000/mm^3
  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056056

  Hide Study Locations
Locations
Austria
Allgemeines Krankenhaus - Universitatskliniken Recruiting
Vienna, Austria, A-1090
Contact: Contact Person     43-1-40-400        
Karl-Franzens-University Graz Recruiting
Graz, Austria, A-8010
Contact: Contact Person     43-316-380-4100        
Belgium
Ghent University Recruiting
Gent, Belgium, B-9000
Contact: Contact Person     32-9-264-3033        
U.Z. Gasthuisberg Recruiting
Leuven, Belgium, B-3000
Contact: Contact Person     32-16-34-3322-11        
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Contact Person     45-3531-3531        
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, FIN-00029
Contact: Contact Person     358-9-4711        
France
Centre Hospitalier Universitaire Henri Mondor Recruiting
Creteil, France, 94010
Contact: Contact Person     33-1-49-812-590        
CHR Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Contact Person     33-2-40-083-271        
Germany
Hospital Universitario Insular de Gran Canaria Recruiting
Tuebingen, Germany, D-72076
Contact: Contact Person     34-92-844-4000        
Klinikum der Stadt Mannheim Recruiting
Mannheim, Germany, D-68135
Contact: Contact Person     49-621-383-3833        
Klinikum Minden Recruiting
Minden, Germany, D-32423
Contact: Contact Person     49-571-801-4810        
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg Recruiting
Wuerzburg, Germany, D-
Contact: Contact Person     49-931-201-700-00        
Southwest German Cancer Center at Eberhard-Karls-University Recruiting
Tuebingen, Germany, D-72076
Contact: Contact Person     49-7071-292-711        
Hungary
County Hospital Recruiting
Kaposvar, Hungary, H-7400
Contact: Contact Person     36-82-501-300        
Semmelweis University Recruiting
Budapest, Hungary, 1085
Contact: Contact Person     36-1-317-0891        
Israel
Rabin Medical Center - Beilinson Campus Recruiting
Petah-Tikva, Israel, 49100
Contact: Contact Person     972-3-937-7377        
Italy
Istituto Dermopatico Dell' Immacolata Recruiting
Rome, Italy, 00167
Contact: Contact Person     Not Available        
Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Contact Person     39-030-395-823        
Universita di Torino Recruiting
Turin, Italy, 10126
Contact: Contact Person     39-011-670-5955        
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 CA
Contact: Contact Person     31-71-526-9111        
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Contact Person     34-93-227-5400 ext. 2262        
Hospital de la Santa Cruz i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Contact Person     34-3-291-91-25        
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08907
Contact: Contact Person     34-93-260-7812        
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Contact Person     34-91-741-7780        
Hospital Universitario Nuestra Senora de la Candelaria Recruiting
Santa Cruz de Tenerife, Spain, 38003
Contact: Contact Person     34-922-602-170        
Switzerland
UniversitaetsSpital Zuerich Recruiting
Zurich, Switzerland, CH-8091
Contact: Contact Person     41-1-255-1111        
United Kingdom, England
St. Thomas' Hospital Recruiting
London, England, United Kingdom, SE1 9RT
Contact: Contact Person     44-20-792-892-92 ext. 1333        
United Kingdom, Scotland
Royal Infirmary of Edinburgh at Little France Recruiting
Edinburgh, Scotland, United Kingdom, EH16 4SA
Contact: Contact Person     44-131-536-1000        
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Sean J. Whittaker, MD St. Thomas' Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000271933, EORTC-21011
Study First Received: March 6, 2003
Last Updated: August 27, 2009
ClinicalTrials.gov Identifier: NCT00056056     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Anticarcinogenic Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Mycosis Fungoides
Protective Agents
Pharmacologic Actions
Mycoses
Lymphatic Diseases
Photosensitizing Agents
Neoplasms
Radiation-Sensitizing Agents
Bexarotene
Methoxsalen
Therapeutic Uses
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Dermatologic Agents
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on November 27, 2009