Trial | NCT00747903  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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 Started
Feb 29
2008
Primary Completion
Dec 31
2010
Anticipated
Last Update
Jan 10
2014
Estimate

Drug aminolevulinic acid hydrochloride

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
No Results Posted