Non-melanomatous Skin Cancer Clinical Trial
Official title:
Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be
effective in treating patients with skin cancer.
PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in
treating patients with skin cancer.
OBJECTIVES:
- Characterize the penetration of topically applied aminolevulinic acid (ALA) into the
lesions of patients with primary basal cell and squamous cell carcinomas.
- Quantitate the depth of fluorescence achievable with varying application periods of ALA
in these patients.
- Compare the results of tissue fluorescence with surface fluorescence measurements in
these patients.
OUTLINE: This is a randomized study. Patients are stratified according to lesion type
(superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients
within each group are randomized to receive one of two application times: 4-5 or 20-24 hours
in duration.
Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an
occlusive dressing placed over the lesion. After the randomized treatment duration has
expired, the dressing is removed and quantitative protoporphyrin IX fluorescence
measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine
surgical excision is then performed on the carcinoma.
Patients return after one to two weeks for a follow-up examination and suture removal.
PROJECTED ACCRUAL: 54 patients will be accrued within 10 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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