Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Non-melanomatous Skin Cancer Clinical Trial

Official title:

Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00663910
• Other study ID #: CASE-9Z07-CC417
• Secondary ID: P30CA043703P01CA
• Status: Terminated
• Phase: Phase 0
• First received: April 19, 2008
• Last updated: December 30, 2016
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Non-melanomatous Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• 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®.

Procedure:
• 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.
• diagnostic imaging technique
Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.
• therapeutic conventional surgery
The non-melanoma skin cancer will be excised using the MOHS procedure.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration		Day 1	No
Secondary	In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods		Day 1	No
Secondary	Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors		Day 1	No
Secondary	Establishment of a skin cancer tissue bank		Day 1	No