Intratumoral/interstitial therapy of glioblastoma

这项II期试验的目的是：主要：评估HN-66000在难治性和进行性多形性胶质母细胞瘤（GBM）或间变性星形细胞瘤（AA）患者的瘤内/间质局部治疗的疗效。通过比较HN-66000治疗前对比增强MRI的肿瘤体积测量值与两次分别使用HN-66000治疗后的肿瘤体积测量值来确定疗效。通过观察和询问患者的不良事件，评价HN-66000在瘤内/间质局部治疗中的安全性。所有患者将接受广泛的神经学检查、核磁共振检查以及血液和尿液化学分析。次要目的：评估和比较组织学类型（GMB或AA）、肿瘤组织中转移受体表达程度和血清抗白喉抗体滴度之间可能的疗效差异。估计6个月和12个月的生存率。

The objectives of this Phase II trial are: Primary: To evalute the efficacy of intratumoral/interstitial regional therapy with HN-66000 in patients with refractory and progressive glioblastoma mulitforme (GBM) or anaplastic astrocytoma (AA). Efficacy will be determined by comparing measurement of tumor volume on contrast-enhanced MRI before treatment with HN-66000 with measurements of tumor volume made after two separate treatments with HN-66000. To evaluate the safety of intratumoral/interstitial regional therapy with HN-66000 by observing and questioning patients for adverse events. All patients will be followed with extensive neurological examinations, MRI examinations, and blood and urine chemistry profiles. Secondary: To evaluate and compare possible differences in efficacy between histological types (GMB or AA), degree of transferring receptor expression in tumor tissue and serum antidiphtheria antibody titer levels. To estimate survival at 6 and 12 months.