Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome
Eligibility 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
Sites / Locations
- Karl-Franzens-University Graz
- Allgemeines Krankenhaus - Universitatskliniken
- Ghent University
- U.Z. Gasthuisberg
- Bispebjerg Hospital
- Helsinki University Central Hospital
- Centre Hospitalier Universitaire Henri Mondor
- CHR Hotel Dieu
- Klinikum der Stadt Mannheim
- Klinikum Minden
- Hospital Universitario Insular de Gran Canaria
- Southwest German Cancer Center at Eberhard-Karls-University
- Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
- Semmelweis University
- County Hospital
- Rabin Medical Center - Beilinson Campus
- Spedali Civili di Brescia
- Istituto Dermopatico Dell' Immacolata
- Universita di Torino
- Leiden University Medical Center
- Hospital de la Santa Cruz i Sant Pau
- Hospital Clinic de Barcelona
- Hospital Universitari de Bellvitge
- Hospital Universitario 12 de Octubre
- Hospital Universitario Nuestra Senora de la Candelaria
- UniversitaetsSpital Zuerich
- St. Thomas' Hospital
- Royal Infirmary of Edinburgh at Little France
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bexarotene and PUVA
PUVA