Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

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

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.

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.

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