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| 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 |
| Estimated Enrollment: | 145 |
| Study Start Date: | January 2003 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed mycosis fungoides
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
Willing and able to avoid prolonged exposure to the sun
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study 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 | |
| Investigator: | Sean J. Whittaker, MD | St. Thomas' Hospital |
More Information
| 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 |
|
stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
|
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 |