Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

NCT ID: NCT00663910

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-10-31

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.

Conditions

Non-melanomatous Skin Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Aminolevulinic 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®.

Intervention Type: DRUG

biopsy

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.

Intervention Type: PROCEDURE

diagnostic imaging technique

Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.

Intervention Type: PROCEDURE

therapeutic conventional surgery

The non-melanoma skin cancer will be excised using the MOHS procedure.

Intervention Type: PROCEDURE

Other Intervention Names

ALA; Aurora dosimeter

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward V. Maytin, MD, PhD

Role: STUDY_CHAIR

The Cleveland Clinic

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

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P01CA084203

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CC417

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-9Z07-CC417

Identifier Type: -

Identifier Source: org_study_id