Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

December 30, 2016 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Non-melanomatous Skin Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration Time Frame: Day 1	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods Time Frame: Day 1	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	Day 1
Establishment of a skin cancer tissue bank Time Frame: Day 1	Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Edward V. Maytin, MD, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

April 19, 2008

First Submitted That Met QC Criteria