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Photodynamic Therapy in Treating Patients With Skin Cancer

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: November 1, 1999
Last updated: August 2, 2013
Last verified: August 2013

November 1, 1999
August 2, 2013
February 1997
April 2009   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002975 on Archive Site
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Photodynamic Therapy in Treating Patients With Skin Cancer
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

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.


  • 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.

Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-melanomatous Skin Cancer
  • Precancerous Condition
Drug: aminolevulinic acid
Experimental: PDT
4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
Intervention: Drug: aminolevulinic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2010
April 2009   (final data collection date for primary outcome measure)


  • 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
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000065494, RPCI-DS-96-55, NCI-G97-1224
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Nathalie Zeitouni, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP