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Prospective Randomized Clinical Trial of Celecoxib for the Control of Symptomatic Plexiform Neurofibroma in Neurofibromatosis 1

机译:塞来昔布用于控制神经纤维瘤病中症状性丛状神经纤维瘤的前瞻性随机临床试验1

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The purpose of the project was to develop the infrastructure necessary to run a multi-center clinical trial of a novel medical therapy for patient with NF1. To this end, a consortium of seven institutions was developed, each with expertise in treating patients with NF1 or tumors of the nervous system. Important accomplishments include the establishment of a clinical protocol for running the trial; naming a Steering Committee, Data and Safety Monitoring Board, and Medical Monitor; and partnering with Pfizer, Inc, and PharmaContent, Inc. to run the trial. The protocol was submitted for approval at the Institutional Review Board at the sponsoring institution. This work culminated in the submission of a application for a Clinical Trial Award through the Department of Defense in June, 2005 (month 6 of the grant period).

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