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。所列机构为中心，不一定是研究者所在机构。恶性胶质瘤是成人中最常见的脑肿瘤，每年有10，000 - 15，000例新发病例。手术、放疗和化疗等治疗方法使这些脑肿瘤患者的生存期从14周延长到1年;然而，一种恶性胶质瘤，多形性胶质母细胞瘤，仍然是5.5%先前的临床研究已经表明，脑内施用的单剂量的G207是良好耐受的，并且表明G207可以诱导肿瘤发生。回归分析本研究旨在评价G207联合放疗对恶性胶质瘤患者放疗和/或化疗后进展性生长的影响。研究设计为两阶段试验。第一阶段：G207将通过5次立体定向注射0.2 mL至肿瘤区域，然后在注射后24小时进行局灶性放射治疗来施用。由于G207在该水平下未显示毒性，因此将采用降级方案。一旦确定了第1阶段的最大耐受剂量，将在G207的该剂量水平下重复该方案，然后进行伽玛刀放射外科手术。本研究的目的如下：获得复发性/进展性恶性胶质瘤患者肿瘤内接种G207后接受放疗的安全性信息。将患者分组至2-9例患者的小型给药队列。