OBJECTIVES:

• Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen (PUVA) in patients with stage IB or IIA cutaneous T-cell lymphoma.
• Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive a lower dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26.
• Arm II: Patients receive a higher dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy as in arm I.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous T-cell lymphoma within the past year

• Stage IB or IIA disease

  • No prior diagnosis more advanced than stage IIA disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 9 g/dL
• WBC at least 2,000/mm^3
• Absolute lymphocyte count normal

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN
• No significant hepatic dysfunction

Renal:

• Creatinine no greater than 2 times ULN
• Calcium no greater than 11.5 mg/dL
• No significant renal dysfunction

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 1 month after study participation
• Fasting triglycerides normal (fenofibrate or another anti-lipemic agent allowed except gemfibrozil)
• HIV negative
• No other concurrent known serious medical illness or infection that would preclude study participation
• No prior uncontrolled hyperlipidemia
• No pancreatitis or clinically significant risk factors for developing pancreatitis
• No known allergy or sensitivity to retinoid class drugs or fenofibrate or idiosyncratic reactions to psoralen compounds
• No history of light-sensitive disease states (e.g., lupus, porphyria, or albinism) or aphakia
• No prior or concurrent melanoma or invasive squamous cell carcinoma
• No pre-existing gallbladder disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior systemic anticancer interferon
• No prior systemic anticancer denileukin diftitox

Chemotherapy:

• At least 30 days since prior topical anticancer carmustine or mechlorethamine
• No prior systemic anticancer alkaloid chemotherapy
• No other concurrent systemic or topical anticancer chemotherapy (e.g., methotrexate or cyclophosphamide)

Endocrine therapy:

• At least 30 days since prior topical anticancer corticosteroids
• No concurrent systemic or topical anticancer corticosteroids

Radiotherapy:

• No concurrent localized radiotherapy to specific study lesions except at investigator's discretion

Surgery:

• Not specified

Other:

• No prior systemic anticancer therapy
• At least 30 days since prior topical anticancer therapy (e.g., ultraviolet B light or psoralen-ultraviolet-light therapy)
• At least 30 days since prior participation in another investigational drug study
• At least 30 days since prior vitamin A (at doses of more than 15,000 IU/day) or other retinoid class drugs
• No other concurrent systemic or topical anticancer drugs or therapies
• No other concurrent systemic retinoid class drugs, beta-carotene compounds, or vitamin A (at doses of more than 15,000 IU/day)
• No other concurrent investigational medication
• No concurrent gemfibrozil
• No concurrent statin class anti-lipemics combined with fibrate class anti-lipemics (e.g., atorvastatin with fenofibrate)