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临床试验/NCT00253474
NCT00253474已完成1 期

A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas

National Institutes of Health Clinical Center (CC)8 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
36
试验地点
8

研究概览

简要总结

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.

详细描述

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2/2005.)
  • Determine the toxicity profile of this drug in these patients.

Secondary

  • Obtain, preliminary, information about the efficacy of this drug in these patients.
  • Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.
  • Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
1 Year 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

研究点 (8)

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