Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer - Full Text View

Sponsored by:	DUSA Pharmaceuticals, Incorporated
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00747903

Purpose

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.

Condition	Intervention	Phase
Non-Melanomatous Skin Cancer	Drug: aminolevulinic acid	Phase II

MedlinePlus related topics: Cancer Skin Cancer

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Efficacy [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747903

Locations

United States, New York
Laser and Skin Surgery Center of New York	Recruiting
New York, New York, United States, 10028
Contact: Diana Santanello 212-686-7306

Sponsors and Collaborators

DUSA Pharmaceuticals, Incorporated

Investigators

Investigator:

Diana Santanello

Laser and Skin Surgery Center of New York

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Laser and Skin Surgery Center of New York ( Roy G. Geronemus )
Study ID Numbers:	CDR0000613601, DUSA-PDT-BCC-06
Study First Received:	September 5, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00747903
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

basal cell carcinoma of the skin
recurrent skin cancer

Study placed in the following topic categories:

Skin Diseases
Carcinoma, Basal Cell
Skin Neoplasms
Recurrence

Aminolevulinic Acid
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Photosensitizing Agents
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents

Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Basal Cell
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009