Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1) (NCT01682811) | Clinical Trial Compass
CompletedPhase 1
Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)
United States20 participantsStarted 2012-03-12
Plain-language summary
GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.
SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and efficacy of PDT using 5-aminolevulinic acid (ALA) and 633 nm light in the treatment of benign dermal neurofibromas.
Specifically, the primary goal of the current study is to determine the maximum tolerable light doses that can be administered to subjects undergoing topical photoillumination photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical Solution.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18 years or older.
✓. NF1 will be diagnosed by American Academy of Neurology guidelines.
✓. Location of tumor: cutaneous, trunk or limbs only.
✓. Tumor type: superficial dermal neurofibromas, less than or equal to 4 mm deep.
✓. Growth confirmation: direct measurement for the dermal neurofibromas, ruler and photo-volumetric method.
✓. Informed consent of subject.
✓. Absence of any other malignancy.
✓. Only failures to meet criteria 1-6 due to the primary disease will be disqualifying
Exclusion criteria
✕. Life expectancy less than 1 year.
✕. Pregnancy.
✕. Inability to consent.
What they're measuring
1
Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX
Timeframe: 24 hours
2
Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light