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

Completed · Phase 1

Conditions studied: Basal Cell Carcinoma of the Skin, Pain, Recurrent Skin Cancer

In brief

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

Key facts

Study ID

NCT01292668

Run by

Roswell Park Cancer Institute

People needed

21

Starts

2011-03-01

Expected to finish

2014-09-01

Last updated by the study team

2014-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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