Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Early Phase 1TerminatedNCT00663910

The Cleveland Clinic18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non-melanomatous Skin Cancer

Interventions

Aminolevulinic AcidDRUG

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®.

biopsyPROCEDURE

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.

diagnostic imaging technique

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration

Time frame: Day 1

Secondary Outcomes

In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods

Time frame: Day 1

Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors

Time frame: Day 1

Establishment of a skin cancer tissue bank

Time frame: Day 1

Data from ClinicalTrials.gov

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