CLINICAL TRIAL: HCRF FOR PATIENTS WITH MALIGNANT BRAIN TUMOR WHO REQUIRE HIGH-DO

临床试验：HCRF 适用于需要高剂量治疗的恶性脑肿瘤患者

• 批准号: 7717889
• 负责人: Lawrence D Recht
• 金额: $ 0.08万
• 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: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717889
• 关键词: Blinded; Brain Edema; Chronic; Clinical; Clinical Trials; 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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项 GCRC 方案 #893 的扩展使用研究，方案 ID：1654，标题：NTI 0303：一项 III 期随机、双盲、地塞米松节约研究，比较人类促肾上腺皮质激素释放因子 (hCRF) 与安慰剂，以控制需要长期给药的恶性脑肿瘤患者的瘤周脑水肿相关症状高剂量 地塞米松。 这项开放标签、长期使用研究向所有参与盲法研究 NTI 0302 或 NTI 0303 的患者开放，包括可能提前停止盲法研究药物但完成了方案规定的随访期的患者。 本研究的目的是检查人促肾上腺皮质激素释放因子（hCRF）对于需要地塞米松治疗瘤周脑水肿的患者的长期安全性和耐受性。 该研究将评估 hCRF 和类固醇毒性的整体安全性。在整个研究过程中，治疗医生将被要求尝试并维持基线地塞米松的最大可能减少。在每月访视时，将记录当前的每日地塞米松剂量，以及自上次访视以来的最高和最低每日地塞米松剂量。神经系统和临床状态将通过信号神经症状评估、卡诺夫斯基表现评分、10 项神经系统检查评分和 FACT-Br 生活质量模块结果来衡量。