Non-melanomatous Skin Cancer, Precancerous Condition
Conditions
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin, actinic keratosis
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.
Interventions
DRUGaminolevulinic acid
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No known photosensitivity disease * No porphyria or hypersensitivity to porphyrins PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior treatment with systemic photosensitizer that would cause residual cutaneous photosensitivity during study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | One Year |
Countries
United States
Participant flow
Recruitment details
Study was activated in February, 1997, which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI died and left incomplete data, and study was terminated in April, 2009.
Participants by arm
| Arm | Count |
|---|---|
| Photodynamic Therapy Using 20% Topical ALA 4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation | 175 |
| Total | 175 |
Baseline characteristics
| Characteristic | Photodynamic Therapy Using 20% Topical ALA |
|---|---|
| Age Continuous | 58.0 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Response Rate
Time frame: One Year
Population: PI died, leaving incomplete data. Data not analyzed.