Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II

Who is this study for? Patients with benign dermal neurofibromas
What treatments are being studied? Aminolevulinic acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
United States
Wisconsin
Donald G Basel
RECRUITING
Milwaukee
Contact Information
Primary
Donald G Basel, MD
dbasel@mcw.edu
414-266-4921
Backup
Paula Engelking, BS, CRC
pengelki@mcw.edu
414-266-3289
Time Frame
Start Date: 2016-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Experimental: PDT Treatment
Each subject will have either placebo or Levulan Kerastick topical application applied to matched sets of neurofibromas. Each subject will have both sets, in order to serve as his/her own control subject.~16 to 24 hours post study drug treatment, both sets of neurofibromas, Levulan and placebo treated, will be irradiated with red light (630 nm) from an Omnilux Revive light device at 100 mW/cm2 for 1000 seconds (16.7 minutes).
Sponsors
Leads: Donald Basel

This content was sourced from clinicaltrials.gov