Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2008 |
Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
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.
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.
- 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.
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
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