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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00657202 |
Purpose
The purpose of this research study is to determine if ranibizumab can prevent the growth of neurofibromas. We will also be collecting extra blood and serum samples to help us learn more about NF1. Ranibizumab is a drug that affects the development of blood vessels that feed tumors. It targets a substance in the body called VEGF (Vascular Endothelial Growth Factor). VEGF helps tumors to grow and survive by supporting the growth of blood vessels that bring nutrients to the tumor. VEGF is made by cancerous tumors and also by non-cancerous tumors such as neurofibromas.
| Condition | Intervention |
|---|---|
|
Neurofibromatosis Type 1 Cutaneous Neurofibromas |
Drug: Ranibizumab |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Ranibizumab (Lucentis) for Neurofibromas Associated With Neurofibromatosis 1 |
| Estimated Enrollment: | 11 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Scott Plotkin, MD, PhD | 617-726-3650 |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Scott Plotkin, MD, PhD | Massachusetts General Hospital |
More Information
| Responsible Party: | Scott Plotkin, MD, PhD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00657202 History of Changes |
| Other Study ID Numbers: | 07-332 |
| Study First Received: | March 27, 2008 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
NF1 neurofibroma ranibizumab Lucentis |
|
Neurofibroma Neurofibromatosis 1 Osteitis Fibrosa Cystica Neurofibromatoses Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Peripheral Nervous System Neoplasms Nervous System Neoplasms Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases |