Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy. PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.

Detailed Description
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OBJECTIVES: To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration. To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods. To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors. To establish a skin cancer tissue bank. OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.

Official Title
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Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: Aminolevulinic Acid
* Procedure: biopsy
* Procedure: diagnostic imaging technique
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips PATIENT CHARACTERISTICS: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity to aminolevulinic acid or any component of this medication PRIOR CONCURRENT THERAPY: Concurrent immunosuppressive or chemotherapeutic medications allowed Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed No concurrent participation in another clinical trial No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers No concurrent medical therapy or radiotherapy for other cancers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aminolevulinic Acid|On Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®.|
|Procedure: biopsy|Then local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat.|
|Procedure: diagnostic imaging technique|Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.|
|Procedure: therapeutic conventional surgery|The non-melanoma skin cancer will be excised using the MOHS procedure.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods |  | Day 1 | 
| Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors |  | Day 1 | 
| Establishment of a skin cancer tissue bank |  | Day 1 | 

 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, recurrent skin cancer