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Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

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ClinicalTrials.gov Identifier: NCT00663910
Recruitment Status : Terminated (Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.)
First Posted : April 22, 2008
Last Update Posted : January 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Non-melanomatous Skin Cancer Drug: Aminolevulinic Acid Procedure: biopsy Procedure: diagnostic imaging technique Procedure: therapeutic conventional surgery Early Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
Study Start Date : March 2008
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

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

Secondary Outcome Measures :
  1. In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods [ Time Frame: Day 1 ]
  2. Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors [ Time Frame: Day 1 ]
  3. Establishment of a skin cancer tissue bank [ Time Frame: Day 1 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663910


Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Edward V. Maytin, MD, PhD The Cleveland Clinic
More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00663910     History of Changes
Other Study ID Numbers: CASE-9Z07-CC417
P30CA043703 ( U.S. NIH Grant/Contract )
P01CA084203 ( U.S. NIH Grant/Contract )
CC417 ( Other Identifier: Case Comprehensive Cancer IRB )
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared.

Keywords provided by The Cleveland Clinic:
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
recurrent skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents