Non-melanomatous Skin Cancer | Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
Non-melanomatous Skin Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Non-melanomatous Skin Cancer
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:aminolevulinic acid hydrochloride
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: February 2008
Phase: Phase 2
Primary Outcome: Safety
Study sponsors, principal investigator, and references
Principal Investigator: Diana Santanello
Lead Sponsor: Laser and Skin Surgery Center of New York