Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)

Completed · Phase 1

Conditions studied: Neurofibromatoses

In brief

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.

Key facts

Study ID

NCT01682811

Run by

Harry T Whelan, MD

People needed

20

Starts

2012-03-12

Expected to finish

2016-07-07

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with NF1 will be selected for photodynamic therapy on the following 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

You may not qualify if…

• Subjects will be excluded from participation in the study on the basis of the following:
• Life expectancy less than 1 year.
• Pregnancy.
• Inability to consent.
• Cutaneous photosensitivity to the wavelengths used to activate 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. -

Where it is running

• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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