Photodynamic Therapy in Treating Patients With Skin Cancer
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.
Non-melanomatous Skin Cancer
Drug: aminolevulinic acid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Efficacy [ Designated as safety issue: No ]
- Range of biological variations in PpIX levels and distributions within lesions and skin [ Designated as safety issue: No ]
- Range of biological variations in the rate and extent of treatment-induced photobleaching of the PpIX and recovery from photobleaching [ Designated as safety issue: No ]
- Range of biological variations in photodynamic therapy (PDT)-induced clinical epidermal toxicity [ Designated as safety issue: No ]
- Range of biological variations in PDT-induced tissue damage and host responses on a microscopic level [ Designated as safety issue: No ]
- Range of biological variations in the rate and extent of treatment-induced photobleaching within lesions and skin [ Designated as safety issue: No ]
|Study Start Date:||February 1997|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Nathalie Zeitouni, MD||Roswell Park Cancer Institute|