CLINICAL TRIAL: PERITUMORAL BRAIN EDEMA IN PATIENTS WITH PRIMARY MALIGNANT GLIOM

临床试验：原发性恶性胶质瘤患者的瘤周脑水肿

• 批准号: 7717893
• 负责人: Lawrence D Recht
• 金额: $ 0.15万
• 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/7717893
• 关键词: Brain Edema; Clinical; Clinical Trials; 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 - descriptor; 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 Week 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 mg/d, 1-8 mg/d 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 Week 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。 这项研究的目的是检查人皮质激素释放因子（HCRF）的安全性和疗效，而不是地塞米松的原发性恶性肿瘤患者，这些患者需要增加地塞米松剂量以控制周围脑脑脑水肿的症状。 主要疗效终点将比较响应者，即在第1周结束时显示出改善的每个治疗组中的患者比例，并在第2周结束时验证该反应。 改进定义为： a）对10个项目神经系统检查的总体评分较低 至少相对于基线，至少25％ b）Karnofsky的性能得分不变或相对增加 到基线，然后 c）在 - 贝斯利后，地塞米松剂量没有超过 1天，最大允许的增加小于4毫克 当天 次要终点将评估第2周以后的响应耐用性，治疗失败的时间，对每个治疗组中的地塞米松使用的检查以及通​​过信号神经系统症状评分测量的神经/临床状况以及生活质量模块的事实。 在为期8周的试验过程中，将评估HCRF和类固醇毒性的总体安全性。 120名随机分为两个臂的患者将参加这项双盲，正控制的8周研究。 患者将通过（1）基线（2）地塞米松剂量（2）基线（0 mg/d，1-8 mg/d和9-24 mg/d）和（3）10 - 独立神经学检查评分（3-4，5-8，> 8）。 在研究治疗期间，必须在基线，第1周和第2周进行患者神经系统评估。最终的4周随访将在第12周进行。在最终的随访访问中，患者可以参加公开 - 标签，HCRF（NTI 0501）的扩展使用研究。扩展使用的研究是GCRC协议＃909。