Non-melanomatous Skin Cancer
Conditions
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer
Brief summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy. PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.
Detailed description
OBJECTIVES: * To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration. * To obtain in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods. * To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors. * To establish a skin cancer tissue bank. OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.
Interventions
DRUGAminolevulinic Acid
On Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®.
PROCEDUREbiopsy
Then local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat.
PROCEDUREdiagnostic imaging technique
Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.
PROCEDUREtherapeutic conventional surgery
The non-melanoma skin cancer will be excised using the MOHS procedure.
Sponsors
National Cancer Institute (NCI)
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm * No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to aminolevulinic acid or any component of this medication PRIOR CONCURRENT THERAPY: * Concurrent immunosuppressive or chemotherapeutic medications allowed * Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed * Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed * Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed * No concurrent participation in another clinical trial * No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers * No concurrent medical therapy or radiotherapy for other cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods | Day 1 |
| Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors | Day 1 |
| Establishment of a skin cancer tissue bank | Day 1 |
Outcome results
None listed