NABTT 0306 EMD 121974 TRIAL

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项临床试验的目的是评估EMD 121974(西仑肽)在新诊断的多形性胶质母细胞瘤放射治疗的同时，每周两次，同时给予替莫唑胺1小时输注的安全性。这项研究还将有助于估计新诊断的多形性胶质母细胞瘤患者的总体存活率，这些患者在接受EMD 121974治疗的同时，同时辅以替莫唑胺和放射治疗。次要目标包括：估计和比较在放射治疗的同时使用EMD 121974同时使用替莫唑胺和辅助剂替莫唑胺治疗的新诊断患者的低剂量治疗组和高剂量治疗组之间的总存活率。确定EMD 121974与替莫唑胺同时和辅助放射治疗时的毒性。评估单个患者的分子图谱，并将分子表达图谱与临床结果相关联。最后利用MR灌注成像技术对新诊断的多形性胶质母细胞瘤的肿瘤血流量、肿瘤血流量和通透性比率进行表征，并在使用EMD 121974治疗期间遵循这些参数。恶性胶质瘤是最致命的癌症之一。EMD 121974具有抗血管生成的特性。我

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 objectives of this clinical trial are to assess the safety profile of EMD 121974 (cilengitide) when administered as a one-hour infusion twice weekly concurrently with concomitant and adjuvant temozolomide with radiation therapy for newly diagnosed glioblastoma multiforme. The study also will help to estimate the overall survival in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy. Secondary objectives include: estimating and comparing the overall survival between a low dose treatment group and a high dose treatment group in newly diagnosed patients treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy. Determining the toxicity of EMD 121974 when it is administered in conjunction with concomitant and adjuvant temozolomide with radiation therapy. Evaluating the molecular profile of individual patients and correlate molecular expression profiles with clinical outcomes. And lastly to characterize tumor blood volume, tumor blood flow, and permeability ratios using perfusion MR in newly diagnosed glioblastoma multiforme and follow these parameters during treatment with EMD 121974. Malignant gliomas are among the deadliest form of cancer. EMD 121974 has an antiangiogenic property. I