跳至主要内容
临床试验/NCT00048373
NCT00048373已完成2 期

Treatment of Resistant Langerhans Cell Histiocytosis With Etanercept (ENBREL, IMMUNEX, SEATTLE)

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2001年10月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Response of Langerhans cell histiocytosis

研究概览

简要总结

The purpose of this study is to learn about the response of Langerhans cell histiocytosis (LCH) to Enbrel in patients who have failed to respond to standard therapies. We are also looking specifically at what side effects Enbrel has on patients. We expect to enroll 20 patients on this study and anticipate the subjects active participation to last up to one year.

详细描述

After subjects have completed the pretreatment evaluations, they will receive an injection of Enbrel - the study drug -(given under the skin) twice weekly. If the subjects disease stabilizes or regresses, they may continue to receive treatment for up to 1 year.

Subjects with disease involvement of risk organs (this means patients have disease in their liver, lung, spleen, or bone marrow): will be admitted to the hospital for observation during the first week of administration of Enbrel. If after the first two doses there appears to be no problems, subjects may be followed as an outpatient with twice weekly evaluation visits (similar to those performed before treatment began) until abnormal blood tests have become normal. Then the frequency of clinic visits will decrease and be similar to those described below for subjects without disease involvement of risk organs.

Subjects without disease involvement of risk organs will be treated as an outpatient. While receiving the treatment, subjects may not receive any other chemotherapy agents. Doctors will be monitoring subjects closely for side effects. Most side effects usually disappear after the treatment is stopped. In the meantime, however, the doctor may prescribe medication to keep these side effects under control.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 65 Years(Child, Adult, Older 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

结局指标

主要结局

Response of Langerhans cell histiocytosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth McClain

Professor, Pediatrics-Oncology

Baylor College of Medicine

研究点 (2)

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