Clinical trial NCT00056056 (phase 3, status: terminated)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bexarotene, methoxypsoralen
SMILES: CC1=CC2=C(C=C1C(=C)C1=CC=C(C=C1)C(O)=O)C(C)(C)CCC2(C)C
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed mycosis fungoides

               -  Stage IB or IIA

               -  Confirmed by current or prior diagnostic lesion biopsy

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  Karnofsky 60-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC at least 2,000/mm^3

          -  Hemoglobin at least 9 g/dL

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST and ALT no greater than 2.5 times ULN

        Renal

          -  Creatinine no greater than 2 times ULN

          -  Calcium no greater than 11.5 mg/dL

        Cardiovascular

          -  No New York Heart Association grade III or IV cardiac insufficiency

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study participation* NOTE: *Women using hormonal contraception must also use a
             non-hormonal treatment

          -  Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization)

          -  Willing and able to avoid prolonged exposure to the sun

               -  Willing to limit sun exposure on day of PUVA therapy

          -  No prior intolerance of or unresponsiveness to PUVA therapy

          -  No other prior or concurrent malignant tumor except adequately treated carcinoma in
             situ of the cervix or basal cell or squamous cell skin cancer

          -  No prior pancreatitis

          -  No other concurrent serious illness or infection that would preclude study
             participation

          -  No concurrent excessive alcohol consumption

          -  No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive
             drugs) factors

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance

          -  No known contraindications to study drug

          -  No known hypersensitivity to retinoids or hypervitaminosis A

          -  No uncontrolled diabetes mellitus

          -  No uncontrolled thyroid disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 3 months since prior interferon therapy

        Chemotherapy

          -  No prior systemic combination chemotherapy

          -  No prior participation in another study of bexarotene

          -  At least 3 months since prior topical chemotherapy

        Endocrine therapy

          -  At least 1 month since prior topical corticosteroids

        Radiotherapy

          -  At least 6 months since prior total skin electron beam therapy

          -  At least 1 month since prior superficial radiotherapy

        Surgery

          -  Not specified

        Other

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

          -  At least 3 months since prior photopheresis

          -  At least 1 month since prior UVB/PUVA phototherapy

          -  At least 1 month since prior retinoid class drugs

          -  At least 1 month since prior beta-carotene compounds

          -  At least 1 month since other prior topical medications (e.g., tar baths)

          -  No prior participation in this study

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational drug therapy

          -  No concurrent drugs associated with pancreatic toxicity or known to increase
             triglyceride concentrations