Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

NCT00663910 | Terminated Early Phase 1 DMC

• 4 other identifiers: CASE-9Z07-CC417P30CA043703P01CA084203CC417
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin; recurrent skin cancer

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (3)

• In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods

  Day 1

• Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors

  Day 1

• Establishment of a skin cancer tissue bank

  Day 1

Interventions

Aminolevulinic Acid DRUG

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®.

Also known as: ALA

biopsy PROCEDURE

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.

diagnostic imaging technique PROCEDURE

Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.

Also known as: Aurora dosimeter

therapeutic conventional surgery PROCEDURE

The non-melanoma skin cancer will be excised using the MOHS procedure.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Interventions

Aminolevulinic Acid; Biopsy; X-Rays

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Edward V. Maytin, MD, PhD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2008
• First Posted: April 22, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share