Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00663910
First received: April 19, 2008
Last updated: February 16, 2012
Last verified: February 2012

April 19, 2008
February 16, 2012
March 2008
October 2009   (final data collection date for primary outcome measure)
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00663910 on ClinicalTrials.gov Archive Site
  • In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Establishment of a skin cancer tissue bank [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods [ Designated as safety issue: No ]
  • Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors [ Designated as safety issue: No ]
  • Establishment of a skin cancer tissue bank [ Designated as safety issue: No ]
Not Provided
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Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
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.

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.

Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Non-melanomatous Skin Cancer
  • 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®.
    Other Name: ALA
  • 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.
  • 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.
    Other Name: Aurora dosimeter
  • Procedure: therapeutic conventional surgery
    The non-melanoma skin cancer will be excised using the MOHS procedure.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00663910
CASE-9Z07-CC417, P30CA043703, P01CA084203, CASE-9Z07-CC417
Yes
The Cleveland Clinic
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Edward V. Maytin, MD, PhD The Cleveland Clinic
The Cleveland Clinic
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP