Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer
- Conditions
- Basal Cell Carcinoma of the SkinPainRecurrent Skin Cancer
- Interventions
- Drug: methyl-5-aminolevulinate hydrochloride creamProcedure: laser therapyDrug: photodynamic therapy
- Registration Number
- NCT01292668
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I laser therapy 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 methyl-5-aminolevulinate hydrochloride cream Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes. Group I methyl-5-aminolevulinate hydrochloride cream 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 photodynamic therapy Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes.
- Primary Outcome Measures
Name Time Method Irradiance-dependent pain threshold 30-60 sec after the initial "low" irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the "high" irradiance increase, and every 3-5 min until end of treatment
- Secondary Outcome Measures
Name Time Method Efficacy of treatment in terms of clinical response At 5-7 days, at 6-12 months, and at 24 months
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States