Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed cutaneous T-cell lymphoma

- Stage IB, IIA, IIB, III, or IV

- Measurable or assessable disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 9 g/dL

- WBC at least 1,500/mm^3

- Platelet count at least 70,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT and SGPT no greater than 3 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 3 times ULN

- Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior
to study)

- No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any
other significant liver dysfunction)

Renal:

- Calcium no greater than 11.5 mg/dL

- Creatinine no greater than 2 times ULN

Cardiovascular:

- No myocardial infarction in the past 6 months

- No unstable angina

- No class III or IV congestive heart failure

- No ventricular tachyarrhythmias

Pulmonary:

- No pulmonary infiltrates or clinical pulmonary impairment

Other:

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception for 1 month before,
during, and for 1 month after study therapy

- No known allergy or sensitivity to interferon alfa or bexarotene or other components
of study drugs

- No uncontrolled thyroid disorder

- No other concurrent serious medical illness that would preclude study

- No infection

- No history of pancreatitis

- No history of neuropsychiatric disorders requiring hospitalization

- No history of autoimmune disease that would pose significant risk

- Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No concurrent systemic anticancer chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids

Radiotherapy:

- No concurrent localized radiotherapy to target lesions unless considered

- to have shown progressive disease

Surgery:

- Not specified

Other:

- At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin
A or any other retinoid class drug

- At least 30 days since prior participation in any other investigational drug study

- No concurrent systemic anti-psoriatic drugs or therapies

- No concurrent systemic other anticancer drugs or therapies

- No concurrent gemfibrozil

- No other concurrent investigational medication