Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold patients with skin cancer

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

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

• Patients with 1-2 superficial basal cell carcinoma (sBCC), 0.5 to 2 cm in diameter

• Primary or recurrent lesions may be treated

• Diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment

• Each patient with < 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol Photodynamic Therapy

• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Patients not meeting the above selection criteria

• Lesions which are not suitable for diagnostic measurements

• Patients with >= 8 lesions to be treated

• Carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require Mohs surgery for definitive control

• Lesions over boney prominences

• Patients with porphyrias or known hypersensitivity to porphyrins

• Patients with known photosensitivity diseases

• Patients with allergies to Metvixia (MAL) cream ingredients (peanut and almond oil)

• Patients previously treated with a systemic photo sensitizer within 4 months

• Pregnant or nursing female patients

• Patients unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug