A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma

Inclusion Criteria

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)