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
  Purpose

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 Intervention Phase
Non-melanomatous Skin Cancer
Drug: Aminolevulinic Acid
Procedure: biopsy
Procedure: diagnostic imaging technique
Procedure: therapeutic conventional surgery
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663910

Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Edward V. Maytin, MD, PhD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00663910     History of Changes
Other Study ID Numbers: CASE-9Z07-CC417, P30CA043703, P01CA084203, CASE-9Z07-CC417
Study First Received: April 19, 2008
Last Updated: February 16, 2012
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 16, 2014