Intratumoral/interstitial therapy of glioblastoma

这项第二阶段试验的目标是：主要：评价HN-66000瘤内/间质区域治疗难治性和进展性多形性胶质母细胞瘤或间变性星形细胞瘤的疗效。疗效将通过比较使用HN-66000治疗前对比增强磁共振成像上的肿瘤体积测量和使用HN-66000两次单独治疗后的肿瘤体积测量来确定。通过观察和询问患者不良事件，评价HN-66000瘤内/间质区域治疗的安全性。所有患者都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。第二：评估和比较不同组织学类型(GMB或AA)、肿瘤组织转移受体表达程度和血清抗白喉抗体水平之间可能存在的疗效差异。以估计6个月和12个月的生存期。

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.