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

Inclusion Criteria:

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

1. Age: 18 years or older.
2. NF1 will be diagnosed by American Academy of Neurology guidelines.
3. Location of tumor: cutaneous, trunk or limbs only.
4. Tumor type: superficial dermal neurofibromas, less than or equal to 4 mm deep.
5. Growth confirmation: direct measurement for the dermal neurofibromas, ruler and photo-volumetric method.
6. Informed consent of subject.
7. Absence of any other malignancy.
8. Only failures to meet criteria 1-6 due to the primary disease will be disqualifying

Exclusion Criteria:

Subjects will be excluded from participation in the study on the basis of the following:

1. Life expectancy less than 1 year.
2. Pregnancy.
3. Inability to consent.
4. Cutaneous photosensitivity to the wavelengths used to activate PDT.
5. A diagnosis of porphyria.
6. Allergy to aminolevulinic acid or any of the Topical Solution Vehicle components.
7. Previous chemotherapy within 6 weeks of proposed PDT.
8. Other concurrent tumor therapy. -