Clinical trial NCT00747903: Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
Official title: Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-melanomatous Skin Cancer
Keywords: basal cell carcinoma of the skin
recurrent skin cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
measure: Efficacy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Laser and Skin Surgery Center of New York
name: Diana Santanello
References: