HCRF FOR PATIENTS WITH MALIGNANT BRAIN TUMOR WHO REQUIRE HIGH-DOSE DEXAMETHASONE

HCRF 适用于需要大剂量地塞米松的恶性脑肿瘤患者

• 批准号: 7605237
• 负责人: Lawrence D Recht
• 金额: $ 0.18万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605237
• 关键词: Blinded; Brain Edema; Chronic; Clinical; Computer Retrieval of Information on Scientific Projects Database; Corticotropin-Releasing Hormone; Daily; Dexamethasone; Dose; Double-Blind Method; Funding; Grant; Human; Institution; Karnofsky Performance Status; Label; Malignant neoplasm of brain; Measures; Neurologic; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Placebo Control; Protocols documentation; Quality of life; Randomized; Research; Research Personnel; Resources; Safety; Score; Signal Transduction; Source; Steroids; Symptoms; Title; Toxic effect; United States National Institutes of Health; Visit; follow-up

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an extended-use study for GCRC protocol #893, Protocol ID: 1654, Title: NTI 0303: A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Comparing Corticotropin-Releasing Factor (hCRF) To Placebo For Control Of Symptoms Associated With Periturmoral Brain Edema In Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302 or NTI 0303, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods. The objective of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF) in patients requiring dexamethasone to treat peritumoral brain edema. The study will evaluate overall safety of hCRF and steroid toxicities. Throughout the course of the study, treating physicians will be asked to attempt and maintain a maximum possible reduction in baseline dexamethasone. At monthly visits, the current daily dexamethasone dosing will be recorded, as well as highest and lowest daily dexamethasone dose since the last visit. Neurological and clinical status will be measured by the Signal Neurological Symptom assessment, Karnofsky Performance Score, 10-Item Neurological Exam Score and FACT-Br Quality of Life module results.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此，可以在其他清晰的条目中表示。列出的机构是 对于中心，这不一定是调查员的机构。 这是GCRC协议＃893，协议ID：1654，标题：NTI 0303：III阶段III随机，双盲，右甲虫避免的研究比较人类比较人类比较皮质激素释放因子（HCRF）的安慰剂，以控制人类，这是一项扩展使用的研究。在需要长期给予高剂量地塞米松的恶性脑肿瘤患者中，与心脏性脑浮肿有关的症状。 这项开放标签的扩展使用研究对参加NTI 0302或NTI 0303的所有参加的患者开放，包括可能早日停止盲目研究但完成协议规定的随访期的患者。 这项研究的目的是检查人类皮质激素释放因子（HCRF）的长期安全性和耐受性在需要地塞米松治疗周围脑脑水肿的患者中。 该研究将评估HCRF和类固醇毒性的总体安全性。在整个研究过程中，将要求治疗医生尝试并维持基线地塞米松的最大可能减少。在每月访问时，将记录当前每日地塞米松的剂量，以及自上次访问以来的最高和最低的地塞米松剂量。神经系统和临床状况将通过信号神经系统症状评估，Karnofsky表现评分，10个项目的神经学检查评分和事实 - BR生活质量模块模块结果来衡量。