Methoxsalen

Sponsored by: Millennix

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.

Study Type: Interventional

Study Design: Treatment

Official Title: Phase II Randomized Study of Bexarotene and Ultraviolet A Light Therapy with Methoxsalen (PUVA) in Patients with Stage IB or IIA Cutaneous T-Cell Lymphoma

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.

Ages Eligible for Study: 18 years and above

Genders Eligible for Study: Both

Criteria

* Histologically confirmed cutaneous T-cell lymphoma within the past year

* Stage IB or IIA disease

* No prior diagnosis more advanced than stage IIA disease

A total of 100 patients (50 per treatment arm) will be accrued for this study.

Contact: Study Chair: Joan Guitart, MD

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Tel: 312-695-1413

COPYRIGHT 2003 Journal of Drugs in Dermatology
COPYRIGHT 2004 Gale Group