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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.

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

Intervention / Treatment
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* Drug: methyl-5-aminolevulinate hydrochloride cream
* Drug: photodynamic therapy
* Procedure: laser therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>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. | Drug: methyl-5-aminolevulinate hydrochloride cream<br>* Applied topically<br>* Other names: Metvixia cream;Procedure: laser therapy<br>* Undergo laser light photodynamic therapy<br>* Other names: therapy, laser;|
| Experimental: Group II<br>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. | Drug: methyl-5-aminolevulinate hydrochloride cream<br>* Applied topically<br>* Other names: Metvixia cream;Drug: photodynamic therapy<br>* Undergo light-emitting diode photodynamic therapy<br>* Other names: therapy, photodynamic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in terms of clinical response |  | At 5-7 days, at 6-12 months, and at 24 months |