Clinical trial NCT00030849 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bexarotene
SMILES: CC1=CC2=C(C=C1C(=C)C1=CC=C(C=C1)C(O)=O)C(C)(C)CCC2(C)C
Eligibility 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