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

Inclusion 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