Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Study Overview
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Brief Summary
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RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment against skin cancer. PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.

Detailed Description
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OBJECTIVES: To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma. OUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of aminolevulinic acid followed by non-coherent blue light therapy over approximately 17 minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later. Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16 weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side effects. Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to confirm histological clearance.

Official Title
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Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: aminolevulinic acid hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Biopsy-proven basal cell carcinoma on the trunk or extremities Tumor size ≤ 2 cm in diameter PATIENT CHARACTERISTICS: Willing and able to comply with all follow-up requirements Mentally competent No active, localized, or systemic infections Not immunocompromised No coagulation disorder No photosensitivity or allergy to sunlight Not pregnant or nursing No history of keloid formation No history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis PRIOR CONCURRENT THERAPY: No prior gold therapy No prior radiotherapy to the trunk and extremities More than 24 months since prior oral retinoids (e.g., isotretinoin or acitretin) or photosensitizing drugs (e.g., Declomycin®) More than 1 year since prior collagen or other injections, Botox® injections, chemical peels, dermabrasion, or resurfacing procedures More than 1 month since prior topical retinoid therapy No concurrent aspirin or antioxidants No concurrent anticoagulation medications

Ages Eligible for Study
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Minimum Age: 30 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aminolevulinic acid hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Efficacy |  |  | 

 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, recurrent skin cancer