Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aminolevulinic Acid

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