Precancerous Condition Clinical Trial
Official title:
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
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be
effective in treating patients with skin cancer.
PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that
includes aminolevulinic acid works in treating patients with skin cancer.
OBJECTIVES:
- 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
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