A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Joan Guitart, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
CDR0000069179
NCT00030589
February 2001
Name | Location |
---|---|
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 |