Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Laser and Skin Surgery Center of New York20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-melanomatous Skin Cancer

Interventions

aminolevulinic acid hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Laser and Skin Surgery Center of New York

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Safety

Efficacy

Data from ClinicalTrials.gov

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