Lymphoma Clinical Trial
Official title:
A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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