Trial: Looking for Ages 14 to 30 to Participate in Therapy for Cutaneous Neurofibromas
The Medical College of Wisconsin is looking for people with neurofibromatosis type 1 ages 14 to 30 to participate in a trial of a drug and phototherapy on cutaneous neurofibromas. Learn more below.
Phase II Drug/Phototherapy Trial for Cutaneous NF-1 affecting arms, legs and/ or torso.
Participants age 14 to 30 needed for 3-year clinical trial studying effects of aminolevulinic acid (ALA) combined with red light therapy on growth rate of cutaneous neurofibromas.
This Phase II Trial builds on results of an Phase I study demonstrating that NFs treated with ALA and photodynamic therapy (PTD) absorbed the ALA, while the surrounding skin did not. Some ALA-treated NF cells died (Riccardi et al 9/2019: Children’s Tumor Foundation International Neurofibromatosis Meeting)
In the current Phase II study:
- There are 6 study visits over 3 years:
- Only the first two-day visit involves the experimental treatment.
- At the remaining 5 visits, researchers will monitor NF growth and good/bad side effects of the ALA + PDT.
- NF Photographs and ultrasound measurements will be taken at all 6 visits (allow 2 hours for Follow-up visits).
More Phase II study details:
- At the 2-day experimental treatment visit with the study dermatologist:
- about a half-dozen subcutaneous NFs on arms, legs and/ or trunk will be selected to be studied
- ALA (brand name: Levulan® Kerastick®) will be applied to half the NFs
- Placebo will be applied to other NFs being studied. The placebo is the nonmedicinal solution normally mixed with ALA.
- Total time spent on each of two consecutive days is 2-3 hours.
- Travel reimbursement available to study participants.
- Overnight lodging can be pre-arranged for night between the 2-day visit for participants who live more than 25 miles away from Medical College of Wisconsin Milwaukee Campus.
For Questions and Referrals Contact:
Marsha Malloy RN, BSN, MBA, CCRC
Harry Whelan MD, PI
Medical College of Wisconsin, Dept of Neurology, HUB A4105-1
8701 Watertown Plank Rd, Milwaukee WI 53226