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

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。 本研究的目的是比较人促肾上腺皮质激素释放因子(HCRF)与地塞米松对需要增加地塞米松剂量以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一周结束时出现改善的患者的比例，并在第二周结束时验证该反应。 改进的定义是： A)在10项神经学检查中的总分较低 至少25%，相对于基线，以及 B)卡诺夫斯基绩效分数保持不变或相对增加 至基线，以及 C)地塞米松剂量在基线后不会增加超过 1天，最大允许增加不超过4毫克 那一天 次级终点将评估两周后反应的持久性、治疗失败的时间、每个治疗组使用地塞米松的检查以及通过Signal神经症状评分、Karnofsky操作评分、10项神经检查评分和FACT-BR生活质量模块结果衡量的神经/临床状况。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名患者被随机分成两组，将参加这项为期8周的双盲阳性对照研究。患者将根据(1)多形性胶质母细胞瘤(GBM)和非GBM肿瘤(2)地塞米松基线剂量(0 mg/d、1-8 mg/d和9-24 mg/d)和(3)10项神经学检查评分(3-4、5-8和8)进行分层。在研究治疗期间，患者必须在基线、第一周和第二周进行神经学评估。最后一次为期4周的随访将在第12周进行。在最后一次随访中，患者可以登记参加hCRF的开放式、扩展用途研究(NTI 0501)。扩展用途研究是GCRC协议#909。

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.