Photodynamic Therapy in Treating Patients With Skin Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: aminolevulinic acid hydrochloride
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven basal cell carcinoma or squamous cell carcinoma Candidate for complete surgical excision PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No inflammation or infection of treated area PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Biopsy at least 2 weeks prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aminolevulinic acid hydrochloride|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma of the skin, squamous cell carcinoma of the skin