A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
- 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
- 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
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Joan Guitart, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Stanford University Medical Center||Stanford, California 94305-5408|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Rush-Presbyterian-St. Luke's Medical Center||Chicago, Illinois 60612|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Henry Ford Hospital||Detroit, Michigan 48202|
|Tulane University School of Medicine||New Orleans, Louisiana 70112|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Boston Medical Center||Boston, Massachusetts 02118|
|Northwestern University Medical Center||Chicago, Illinois 60611|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division||New York, New York 10019|
|Austin, Texas 78705|
|Metairie, Louisiana 70006|
|University of Colorado Health Science Center||Aurora, Colorado 80010-0510|
|StonyBrook Dermatology Associates, P.C.||East Setauket, New York 11733|
|Knoxville Dermatology Group, P.C.||Knoxville, Tennessee 37920|