A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses
- Determine the efficacy of aminolevulinic acid and laser irradiation in patients with
superficial and nodular epidermally derived lesions.
OUTLINE: This is a randomized study. Patients are stratified according to lesion type
(superficial basal cell carcinoma [BCC] vs nodular BCC vs superficial squamous cell
carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are
randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).
ALA is topically applied in a cream mixture and an occlusive dressing is placed over the
lesion. After the randomized duration of ALA application has expired, the dressing is
removed and a dye laser is used to treat the lesion.
Patients are followed for 2-5 years after treatment.
PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50
lesions are required for each stratified group.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nathalie Zeitouni, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|