Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma

Phase 2

• Conditions: Lymphoma

• Registration Number: NCT00030589
• Lead Sponsor: Millennix

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-02-14
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2003-10
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (17)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of Colorado Health Science Center; 🇺🇸 Aurora, Colorado, United States

St. Luke's-Roosevelt Hospital Center - Roosevelt Division; 🇺🇸 New York, New York, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Simmons Cancer Center - Dallas; 🇺🇸 Dallas, Texas, United States

Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Knoxville Dermatology Group, P.C.; 🇺🇸 Knoxville, Tennessee, United States

StonyBrook Dermatology Associates, P.C.; 🇺🇸 East Setauket, New York, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Northwestern University Medical Center; 🇺🇸 Chicago, Illinois, United States

Rush-Presbyterian-St. Luke's Medical Center; 🇺🇸 Chicago, Illinois, United States