Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-melanomatous Skin Cancer

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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aminolevulinic acid hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No