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


Phase 0
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Edward V. Maytin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CASE-9Z07-CC417

NCT ID:

NCT00663910

Start Date:

March 2008

Completion Date:

October 2009

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • recurrent skin cancer
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell

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