CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,

CT 2001 用 G207 治疗恶性神经胶质瘤的分阶段 I 期研究，

• 批准号: 7380481
• 负责人: JAMES M MARKERT
• 金额: $ 0.71万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380481
• 关键词: CT; 2001; STAGED; PHASE; STUDY

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. Malignant gliomas are the most common brain tumors in adults with 10,000-15,000 new cases every year. Treatments such as surgery, radiation, and chemotherapy, have extended the survival of patients with these brain tumors from 14 weeks to one year; however, the five year survival rate for one tupe of malignant glioma, glioblastoma multifome, is still 5.5% or less. Previous clinical studies have shown that single doses of G207 administered intracerebrally are well tolerated and suggest that G207 may induce tumor regression. This study is designed to evaluate the effects of G207 followed by radiation therapy in patients with progressive growth of malignant glioma after radiation and/or chemotherapy. The study design is a two stage trial. Stage 1: G207 will be administered by five stereotactic injections of 0.2 mL into regions of the tumor, followed by focal radiation therapy 24 hours post injection. A de-escalation scheme will be utilized since G207 has not shown toxicities at this level. Once the maximum tolerated dose has been established for stage 1, the protocol will be repeated at this dose level of G207 followed by gamma knife radiosurgery. Objectives of the study are as follows: To obtain safety information in patients with recurrent/progressive malignant glioma undergoing intratumoral inoculation with G207 followed by treatment with radiation therapy. Patients will be grouped into small dosing cohorts of 2-9 patients.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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代表。列出的机构适用于该中心，这不一定是调查员的机构。恶性神经胶质瘤是成年人中最常见的脑肿瘤，每年有10,000-15,000例新病例。诸如手术，放射和化学疗法之类的治疗方法已将这些脑肿瘤患者的存活率从14周延长至一年。但是，一个恶性神经胶质瘤（胶质母细胞瘤多组件）的五年存活率仍然为5.5％或更少。先前的临床研究表明，内外施用的单剂量的G207耐受性良好，表明G207可能诱导肿瘤消退。这项研究旨在评估G207的影响，然后是放射治疗对放射和/或化学疗法后恶性神经胶质瘤逐渐生长的患者的影响。研究设计是两级试验。第1阶段：G207将通过五次立体定向注射到0.2 mL的肿瘤区域，然后在注射后24小时进行局灶性放射治疗。由于G207在此水平上没有显示毒性，因此将使用降级方案。一旦建立了第1阶段的最大耐受剂量，该方案将在G207的剂量水平上重复，然后进行伽马刀放射线外科手术。该研究的目标如下：获取经过肿瘤内接种的复发/进行性恶性神经胶质瘤患者的安全信息，然后接受G207的肿瘤内接种，然后进行放射疗法治疗。患者将分为2-9例患者的小剂量队列。