Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Recruitment status was Active, not recruiting
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.
Procedure: UV light therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma|
|Study Start Date:||February 2001|
- 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.
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado Health Science Center|
|Aurora, Colorado, United States, 80010-0510|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Illinois|
|Northwestern University Medical Center|
|Chicago, Illinois, United States, 60611|
|Rush-Presbyterian-St. Luke's Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane University School of Medicine|
|New Orleans, Louisiana, United States, 70112|
|Slidell, Louisiana, United States, 70459-0059|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118-2393|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, New York|
|StonyBrook Dermatology Associates, P.C.|
|East Setauket, New York, United States, 11733|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division|
|New York, New York, United States, 10019|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Tennessee|
|Knoxville Dermatology Group, P.C.|
|Knoxville, Tennessee, United States, 37920|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Tyler, Texas, United States, 75703|
|Study Chair:||Joan Guitart, MD||Robert H. Lurie Cancer Center|