Ranibizumab for Neurofibromas Associated With Neurofibromatosis 1
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|ClinicalTrials.gov Identifier: NCT00657202|
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 1 Cutaneous Neurofibromas||Drug: Ranibizumab||Early Phase 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Ranibizumab (Lucentis) for Neurofibromas Associated With Neurofibromatosis 1|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2013|
Given as an injection into three cutaneous neurofibromas on day 1 of the study treatment.
Other Name: Lucentis
- Determine the effect of inhibiting VEGF signaling on tumor volume and tumor interstitial fluid pressure by local injection of ranibizumab into cutaneous neurofibromas. [ Time Frame: 2 years ]
- To identify angiogenic molecules upregulated in neurofibromas treated with ranibizumab. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657202
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Scott Plotkin, MD, PhD||Massachusetts General Hospital|