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

Phase

Condition

Skin Cancer

Pain

Carcinoma

Treatment

N/A

Clinical Study ID

NCT01292668

I 175410

NCI-2010-02319

Ages > 18
All Genders

Study 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

Eligibility Criteria

Inclusion

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 treatmentsession, 1 lesion per light source, which can be treated the same day as permitted byscheduling; the remaining lesions may be treated as soon as scheduling permits withnon protocol Photodynamic Therapy
Patient or legal representative must understand the investigational nature of thisstudy and sign an Independent Ethics Committee/Institutional Review Board approvedwritten informed consent form prior to receiving any study related procedure

Exclusion

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 orinfiltrating), 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 unsuitablecandidate to receive study drug

Study Design

March 01, 2011

September 30, 2014

Study Description

PRIMARY OBJECTIVES: I. To determine the "low" initial irradiance that causes no or minimal (pain grade of < 4) during the time period during which 90 +/- 10% photo bleaching of protoporphyrin IX (PplX) in the lesion occurs, and which precedes the "high" irradiance portion of MAL/PDT. II. To determine the effects of preceding "low" irradiance on the pain level of the "high" irradiance portion of MAL-PDT. SECONDARY OBJECTIVES: I. To determine the effects of irradiance on lesion perfusion. II. To determine PpIX and Total Vit D content in blood. TERTIARY OBJECTIVES: I. To monitor the clinical outcomes of the treatments for initial response and recurrences. OUTLINE: Patients are randomized to 1 of 2 treatment arms. GROUP I: Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes. GROUP II: Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light-emitting diode treatment for 10-20 minutes. After completion of study treatment, patients are followed up at 5-7 days, at 6-12 months, and at 24 months.

Connect with a study center

Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.