Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Non-melanomatous Skin Cancer Clinical Trial

Official title:

Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00747903
• Other study ID #: CDR0000613601
• Secondary ID: DUSA-PDT-BCC-06
• Status: Recruiting
• Phase: Phase 2
• First received: September 5, 2008
• Last updated: January 9, 2014
• Start date: February 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Basal Cell
• Non-melanomatous Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• aminolevulinic acid hydrochloride

Locations

Country	Name	City	State
United States	Laser and Skin Surgery Center of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Laser and Skin Surgery Center of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety			Yes
Primary	Efficacy			No