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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项针对GCRC协议#893，协议ID：1654，标题：NTI 0303的扩展用途研究：一项III期随机、双盲、地塞米松保守研究-人类比较促肾上腺皮质激素释放因子(HCRF)和安慰剂在控制需要长期服用大剂量地塞米松的恶性脑肿瘤患者脑周水肿相关症状方面的比较。 这项开放标签、延长用途的研究对所有参加NTI 0302或NTI 0303这两项盲法研究的患者开放，包括可能很早就停止了盲法研究药物，但完成了协议规定的随访期的患者。 本研究的目的是观察人促肾上腺皮质激素释放因子(HCRF)在需要地塞米松治疗瘤周脑水肿患者中的长期安全性和耐受性。 这项研究将评估hCRF的整体安全性和类固醇毒性。在整个研究过程中，治疗医生将被要求尝试并保持地塞米松基线的最大可能降幅。在每月的检查中，将记录当前的每日地塞米松剂量，以及自上次检查以来的最高和最低每日地塞米松剂量。神经和临床状态将通过Signal神经症状评估、Karnofsky操作评分、10项神经检查评分和FACT-BR生活质量模块结果进行衡量。

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.