A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides
- Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without
bexarotene yields a significantly higher overall response rate in patients with mycosis
- Compare the overall response rate (CCR and partial response) in patients treated with
- Compare the duration of CCR and time to relapse of patients treated with these
- Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
- Determine the percentage of dropouts by patients treated with these regimens.
- Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, age (60 and under vs over 60), and stage of disease (IB
vs IIA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole
body ultraviolet A therapy. PUVA is given 3 times per week.
- Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms,
treatment repeats for up to 16 weeks in the absence of complete clinical response,
disease progression, or unacceptable toxicity.
Patients are followed every 8 weeks until the first documented progression or relapse.
PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 25 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete clinical response [CCR) and partial response [PR])
35 months after first patient in
Sean J. Whittaker, MD
St. Thomas' Hospital