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Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

Primary Purpose

Non-melanomatous Skin Cancer

Status
Terminated
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Aminolevulinic Acid
biopsy
diagnostic imaging technique
therapeutic conventional surgery
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods
    Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors
    Establishment of a skin cancer tissue bank

    Full Information

    First Posted
    April 19, 2008
    Last Updated
    December 30, 2016
    Sponsor
    The Cleveland Clinic
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00663910
    Brief Title
    Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
    Official Title
    Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Cleveland Clinic
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-melanomatous Skin Cancer
    Keywords
    basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Aminolevulinic Acid
    Other Intervention Name(s)
    ALA
    Intervention Description
    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®.
    Intervention Type
    Procedure
    Intervention Name(s)
    biopsy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    diagnostic imaging technique
    Other Intervention Name(s)
    Aurora dosimeter
    Intervention Description
    Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic conventional surgery
    Intervention Description
    The non-melanoma skin cancer will be excised using the MOHS procedure.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods
    Time Frame
    Day 1
    Title
    Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors
    Time Frame
    Day 1
    Title
    Establishment of a skin cancer tissue bank
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward V. Maytin, MD, PhD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared.

    Learn more about this trial

    Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

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