Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility 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)
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of Arkansas for Medical Sciences
- Stanford University Medical Center
- University of Colorado Health Science Center
- H. Lee Moffitt Cancer Center and Research Institute
- Northwestern University Medical Center
- Rush-Presbyterian-St. Luke's Medical Center
- Tulane University School of Medicine
- Boston Medical Center
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- StonyBrook Dermatology Associates, P.C.
- St. Luke's-Roosevelt Hospital Center - Roosevelt Division
- Ireland Cancer Center
- Knoxville Dermatology Group, P.C.
- Simmons Cancer Center - Dallas
- University of Texas - MD Anderson Cancer Center