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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH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 中心，不一定是研究者的机构。 这是GCRC方案#893的一项扩展使用研究，方案ID：1654，标题：NTI 0303：一项在需要长期给予高剂量地塞米松的恶性脑肿瘤患者中比较促肾上腺皮质激素释放因子（hCRF）与安慰剂控制围脑水肿相关症状的III期、随机、双盲、地塞米松保留研究。 这项开放标签、扩展使用研究对所有参与设盲研究NTI 0302或NTI 0303的患者开放，包括可能提前停用设盲研究药物但完成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）在需要地塞米松治疗瘤周脑水肿的患者中的长期安全性和耐受性。 本研究将评价hCRF的总体安全性和类固醇毒性。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降低。在每月访视时，将记录当前的地塞米松日剂量，以及自上次访视以来的最高和最低地塞米松日剂量。将通过信号神经症状评估、Karnofsky性能评分、10项神经学检查评分和FACT-Br生活质量模块结果测量神经和临床状态。

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.