Conditions: Non-melanomatous Skin Cancer Precancerous Condition
Keywords: basal cell carcinoma of the skin squamous cell carcinoma of the skin actinic keratosis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 180
Healthy volunteers: no

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.

Detailed description:
OBJECTIVES:

* 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.

Arms:
arm 1: 4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation

Interventions: intervention 1: aminolevulinic acid
Intervention descriptions: intervention 1: None

Protocol document: