Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL

Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 12 months in the
absence of disease progression or unacceptable toxicity. Patients also receive UV light
therapy (either PUVA or NB-UVB).

Health-related quality of life is assessed periodically using the FACT-BRM, FACT-G, and
FACT-CTCL questionnaires.

After completion of study therapy, patients are followed for 1 year.

DISEASE CHARACTERISTICS:

- Histologically confirmed mycosis fungoides/Sezary syndrome

- Stage IB-IVA disease

- Erythrodermic disease allowed

- Measurable disease

- One or more indicatory lesions must be designated prior to study entry

PATIENT CHARACTERISTICS:

- ECOG/WHO performance status 0-1

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 75,000/mm³

- WBC ≥ 3,000/mm³

- Serum creatinine ≤ 2.0 mg/dL

- Total serum bilirubin ≤ 2.2 mg/dL

- Serum AST and ALT ≤ 2 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients must be disease free of prior malignancies for ≥ 5 years except currently
treated squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the
cervix, or surgically removed melanoma in situ of the skin (stage 0), with
histologically confirmed free margins of excision

- No history of seizure disorder or severe heart disease

- No acute infections

- Diagnosed depression allowed with receiving appropriate care for depression

PRIOR CONCURRENT THERAPY:

- No prior psoralens with ultraviolet light A or interferon alfa therapy

- More than 4 weeks since prior topical therapy, systemic chemotherapy, or biologic
therapy

- More than 4 weeks since prior surgery and fully recovered

- At least 1 week since prior antibiotics

- No other concurrent standard or investigational topical and systemic antipsoriatic or
anticancer therapies including radiation, steroids, retinoids, nitrogen mustard,
thalidomide, or other investigational agents

- No concurrent topical agents except emollients