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Photodynamic Therapy in Treating Patients With Skin Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002975
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 10, 2013
Last Update Posted : October 10, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

Condition or disease Intervention/treatment Phase
Non-melanomatous Skin Cancer Precancerous Condition Drug: aminolevulinic acid Phase 2

Detailed Description:


  • Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma [BCC] vs nodular BCC vs superficial squamous cell carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).

ALA is topically applied in a cream mixture and an occlusive dressing is placed over the lesion. After the randomized duration of ALA application has expired, the dressing is removed and a dye laser is used to treat the lesion.

Patients are followed for 2-5 years after treatment.

PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50 lesions are required for each stratified group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses
Study Start Date : February 1997
Primary Completion Date : April 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PDT
4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
Drug: aminolevulinic acid

Primary Outcome Measures :
  1. Response Rate [ Time Frame: One Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of 1 of the following:

    • Actinic keratoses
    • Histologically proven superficial or nodular basal cell carcinoma (BCC), squamous cell carcinoma in situ (Bowen's disease), or microinvasive squamous cell carcinoma
  • No nodular BCC greater than 4 mm thick that will not be surgically removed
  • No carcinoma with uncertain margins requiring Moh's surgery



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No known photosensitivity disease
  • No porphyria or hypersensitivity to porphyrins


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No prior treatment with systemic photosensitizer that would cause residual cutaneous photosensitivity during study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002975

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Nathalie Zeitouni, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00002975     History of Changes
Other Study ID Numbers: CDR0000065494
First Posted: January 27, 2003    Key Record Dates
Results First Posted: October 10, 2013
Last Update Posted: October 10, 2013
Last Verified: August 2013

Keywords provided by Roswell Park Cancer Institute:
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
actinic keratosis

Additional relevant MeSH terms:
Skin Neoplasms
Precancerous Conditions
Neoplasms by Site
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents