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Sponsored by: |
Millennix |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030589 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bexarotene Drug: methoxsalen Procedure: UV light therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stage IB or IIA disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 | |
Slidell, Louisiana, United States, 70459-0059 | |
Tulane University School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
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 | |
St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |
New York, New York, United States, 10019 | |
StonyBrook Dermatology Associates, P.C. | |
East Setauket, New York, United States, 11733 | |
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 | |
Tyler, Texas, United States, 75703 | |
Simmons Cancer Center - Dallas | |
Dallas, Texas, United States, 75235-9154 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Joan Guitart, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000069179, MILL-61896, LIGAND-MILL-61896, NU-IRB-837-002 |
Study First Received: | February 14, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030589 |
Health Authority: | United States: Federal Government |
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 |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Mycosis Fungoides Recurrence Mycoses |
Lymphatic Diseases Methoxsalen Bexarotene Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Anticarcinogenic Agents Photosensitizing Agents Neoplasms Neoplasms by Histologic Type Radiation-Sensitizing Agents Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Protective Agents Dermatologic Agents Pharmacologic Actions |