Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II
Donald Basel
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.
Description
Neurofibromas contain a large quantity of fibrous matter, and it is not anticipated that significant reductions in tumor size can be achieved in large, long established, tumors. Cutaneous neurofibromas, which do not usually become apparent until puberty, continue to increase in size and number throughout adulthood. The psychosocial burden of these disfiguring tumors is significant, and the targeted age group (14-30) is at a life period associated with an acceleration in tumor growth. It is for these reasons that the investigators hope to affect the growth rate of less established tumors, in or…
Eligibility
- Age range
- 14–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is 14 years or older. 2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section). 3. Tumor Location: cutaneous, trunk, or limbs only. 4. Tumor Type: superficial dermal neurofibromas ≤4mm deep. 5. Patient has provided written informed consent. 6. Patient is willing to and can comply with study follow-up requirements. 7. Absence of any other malignancy. Exclusion Criteria: 1. Life expectancy less than 3 years. 2. Pregnancy. 3. Cutaneous photosensitivity to the wavelengths used to active PDT. 4. A diagnosis of porphyria. 5. A…
Interventions
- Drugaminolevulinic acid
Drug: Levulan Kerastick Drug: Topical placebo Device: Omnilux Revive Procedure: Photodynamic therapy Other: Tumor growth rate measurements
Location
- Donald G BaselMilwaukee, Wisconsin