Pain Clinical Trial
Official title:
A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
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
Status | Completed |
Enrollment | 21 |
Est. completion date | September 2014 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Efficacy of treatment in terms of clinical response | At 5-7 days, at 6-12 months, and at 24 months | No |
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