Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00747903
First received: September 5, 2008
Last updated: January 9, 2014
Last verified: July 2009
  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 hydrochloride
Phase 2

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

Resource links provided by NLM:


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, 10016
Contact: Roy G. Geronemus, MD    212-686-7306    mail@laserskinsurgery.com   
Sponsors and Collaborators
Laser and Skin Surgery Center of New York
Investigators
Investigator: Diana Santanello Laser and Skin Surgery Center of New York
  More Information

Additional Information:
No publications provided

Responsible Party: Roy G. Geronemus, Laser and Skin Surgery Center of New York
ClinicalTrials.gov Identifier: NCT00747903     History of Changes
Other Study ID Numbers: CDR0000613601, DUSA-PDT-BCC-06
Study First Received: September 5, 2008
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin
recurrent skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms by Site
Neoplasms
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014