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

Abstract

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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Document Details

Document Type
Technical Report
Publication Date
Feb 01, 2005
Accession Number
ADA434638

Entities

People

  • James F. Gusella
  • Scott R. Plotkin

Organizations

  • Massachusetts General Hospital

Tags

DTIC Thesaurus Topics

  • Abstracts
  • Biomedical Research
  • Clinical Trials
  • Computer Programs
  • Consortiums
  • Data Management
  • Department Of Defense
  • Electronic Mail
  • Infrastructure
  • Institutional Review Board
  • Monitoring
  • Neoplasms
  • Nervous System
  • Neurofibromatosis
  • Neuromuscular Diseases
  • Public Health
  • Steering

Fields of Study

  • Medicine

Readers

  • Defense Technology Research and Development.
  • Oncology
  • Technical Research and Report Writing.