Pilot Study of Ranibizumab (Lucentis) for Neurofibromas Associated With Neurofibromatosis 1
- Participants will receive one injection of ranibizumab into 3 tumors on their skin (one
dose per tumor) on day 1 of treatment. One other tumor will be injected with normal
saline solution. The saline solution-called a control-is necessary to determine
whether injections (without medicine) can cause a tumor to shrink. Tumors will be
measured and photographed prior to treatment. Ranibizumab tumors will be removed on
days 8, 15, and 29; the saline treated tumor will be removed on day 29.
- Participants will come into the clinic once a week for a total of 4 weeks and then
again on Days 35. 57 and 85 for post-treatment visits. Some of the following tests and
procedures will be performed: physical examination (including photographs of tumors),
review of current medications, vital signs, routine blood tests, serum chemistry blood
tests, interstitial fluid pressure measurements and tumor samples.
Interventional
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the effect of inhibiting VEGF signaling on tumor volume and tumor interstitial fluid pressure by local injection of ranibizumab into cutaneous neurofibromas.
2 years
No
Scott Plotkin, MD, PhD
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
07-332
NCT00657202
March 2008
December 2013
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |