RecruitingPhase 2

Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

United States30 participantsStarted 2016-08

Plain-language summary

The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

Who can participate

Age range14 Years – 30 Years

SexALL

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Inclusion criteria

✓. Patient is 14 years or older.
✓. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section).
✓. Tumor Location: cutaneous, trunk, or limbs only.
✓. Tumor Type: superficial dermal neurofibromas ≤4mm deep.
✓. Patient has provided written informed consent.
✓. Patient is willing to and can comply with study follow-up requirements.
✓. Absence of any other malignancy.

Exclusion criteria

✕. Life expectancy less than 3 years.
✕. Pregnancy.
✕. Cutaneous photosensitivity to the wavelengths used to active PDT.
✕. A diagnosis of porphyria.
✕. Allergy to aminolevulinic acid or any of the topical solution vehicle components.
✕. Previous chemotherapy within 6 weeks of proposed PDT.
✕. Other concurrent tumor therapy.

What they're measuring

Time to disease progression

Timeframe: 3 years

Trial details

NCT IDNCT02728388

SponsorDonald Basel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Donald G Basel, MD

414-266-4921 dbasel@mcw.edu

View on ClinicalTrials.gov More NEUROFIBROMATOSIS 1 trials