Lymphoma
Conditions
Keywords
stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma. PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.
Detailed description
OBJECTIVES: * Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen (PUVA) in patients with stage IB or IIA cutaneous T-cell lymphoma. * Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive a lower dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26. * Arm II: Patients receive a higher dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy as in arm I. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Interventions
Sponsors
Millennix
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Countries
United States
Outcome results
None listed