PERITUMORAL BRAIN EDEMA IN PATIENTS WITH PRIMARY MALIGNANT GLIOMA; (HCRF) TO DEX

原发性恶性胶质瘤患者的瘤周脑水肿；

• 批准号: 7605243
• 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/7605243
• 关键词: Brain Edema; Clinical; Computer Retrieval of Information on Scientific Projects Database; Corticotropin-Releasing Hormone; Dexamethasone; Dose; Double-Blind Method; End Point; Enrollment; Failure; Funding; Glioblastoma; Grant; Human; Institution; Karnofsky Performance Status; Label; Malignant Glioma; Measures; Neurologic; Neurologic Examination; Patients; Performance; Protocols documentation; Quality of life; Randomized; Relative (related person); Research; Research Personnel; Resources; Safety; Score; Signal Transduction; Source; Steroids; Symptoms; Therapeutic; Time; Toxic effect; United States National Institutes of Health; Upper arm; Visit; Week; day; follow-up; response; tumor; week trial

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. The objective of this study is to examine the safety and efficacy of human corticotropin-releasing factor (hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptoms of peritumoral brain edema. The primary efficacy endpoint will compare responders, i.e. the proportion of patients in each treatment group who show improvement at the end of Wk 1 and verify that response at the end of Week 2. Improvement is defined as: a) a lower overall score on the 10-Item Neurological Examination of at least 25%, relative to Baseline, and b) a Karnofsky Performance score unchanged or increased relative to Baseline, and c) No post-Baseline increase in dexamethasone dose on more than 1 day, with a maximum allowable increase of less than 4 mg on that day. The Secondary endpoints will evaluate the durability of response beyond Week 2, time to therapeutic failure, examination of dexamethasone use in each treatment group and neurological/clinical status as measured by the Signal Neurological Symptom Score, Karnofsky Performance Score, 10-Item Neurological Exam Score and the FACT-Br quality of life module results. Overall safety of hCRF and steroid toxicities will be evaluated over the course of the 8-week trial. 120 patients, randomized into two arms, will participate in this double-blind, positive-controlled, 8-week study. Patients will be stratified by (1) Glioblastoma multiforme (GBM) versus non-GBM tumors (2) dexamethasone dose at Baseline (0, 1-8 and 9-24 mg/d) and (3) 10-Item Neurological Exam Score (3-4, 5- 8, 8). During study treatment, it is mandatory that patient neurological assessments be made at Baseline, Week 1 and Week 2. A final 4-week follow-up will occur at Wk 12. At the final follow-up visit, patients may enroll in an open-label, extended-use study of hCRF (NTI 0501.) The extended-use study is GCRC protocol #909.

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。 本研究的目的是检查人促肾上腺皮质激素释放因子（hCRF）与地塞米松相比，对于需要增加地塞米松剂量来控制瘤周脑水肿症状的原发性恶性胶质瘤患者的安全性和有效性。 主要疗效终点将比较应答者，即每个治疗组中在第 1 周结束时表现出改善的患者比例，并在第 2 周结束时验证该应答。 改进定义为： a) 10 项神经系统检查的总分较低 相对于基线至少 25%，并且 b) 卡诺夫斯基表现分数不变或相对增加 至基线，以及 c) 地塞米松剂量在基线后没有增加超过 1天，最大允许增加量小于4毫克 当天。 次要终点将评估第 2 周后的缓解持久性、治疗失败时间、每个治疗组中地塞米松使用情况的检查以及通​​过信号神经症状评分、卡诺夫斯基表现评分、10 项神经系统检查评分和 FACT-Br 生活质量模块结果测量的神经/临床状态。 hCRF 的总体安全性和类固醇毒性将在为期 8 周的试验过程中进行评估。 120 名患者被随机分为两组，将参加这项为期 8 周的双盲、阳性对照研究。将根据 (1) 多形性胶质母细胞瘤 (GBM) 与非 GBM 肿瘤 (2) 基线时的地塞米松剂量（0、1-8 和 9-24 mg/d）和 (3) 10 项神经系统检查评分（3-4、5-8、8）对患者进行分层。在研究治疗期间，必须在基线、第 1 周和第 2 周对患者进行神经学评估。最终的 4 周随访将在第 12 周进行。在最后一次随访时，患者可以参加 hCRF 的开放标签、扩展使用研究 (NTI 0501)。该扩展使用研究是 GCRC 方案 #909。