Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
Non-melanomatous Skin Cancer
Conditions: official terms
Carcinoma, Basal Cell - Skin Neoplasms
Conditions: Keywords
basal cell carcinoma of the skin, recurrent skin cancer
Study Type
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Name: aminolevulinic acid hydrochloride
Type: Drug
Overall Status
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

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 30 Years
Gender: Both

- Biopsy-proven basal cell carcinoma on the trunk or extremities

- Tumor size ≤ 2 cm in diameter


- 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


- 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
Laser and Skin Surgery Center of New York
New York, New York, United States
Status: Recruiting
Contact: Roy G. Geronemus, MD - 212-686-7306 -
Start Date
February 2008
Laser and Skin Surgery Center of New York
National Cancer Institute (NCI)
Record processing date processed this data on July 28, 2015 page