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首页> 美国卫生研究院文献>Neuro-Oncology >AT-25A PHASE I STUDY OF CONVECTION-ENHANCED DELIVERY OF LIPOSOMAL-IRINOTECAN USING REAL-TIME IMAGING WITH GADOLINIUM IN PATIENTS WITH RECURRENT HIGH GRADE GLIOMA
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AT-25A PHASE I STUDY OF CONVECTION-ENHANCED DELIVERY OF LIPOSOMAL-IRINOTECAN USING REAL-TIME IMAGING WITH GADOLINIUM IN PATIENTS WITH RECURRENT HIGH GRADE GLIOMA

机译：在I-25AT阶段使用G实时成像与ADO对重度高胶质瘤患者的脂质体-亚蛋氨酸对流传输的研究

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BACKGROUND: Chemotherapy for high grade glioma (HGG) is limited by the blood brain barrier. Convection enhanced delivery (CED) improves chemotherapy delivery by utilizing fluid convection obviating the challenges of crossing the BBB while minimizing systemic toxicity. CED of nanoliposomal irinotecan (MM-398) has been optimized in animal models and shows superior anti-tumor activity. An advance in the use of CED is the development of real time CED (RCD), which utilizes MRI to visualize the CED process with the aid of co-convected contrast agents and thus monitor delivery into the brain and to take corrective action. METHODS: With support from an R21 we're conducting a phase I study of CED of liposomal-irinotecan using real-time imaging in patients with recurrent HGG. This is a 3 + 3 dose escalation trial; dose levels are 20 mg, 40 mg, 60 mg, and 80 mg liposomal-irinotecan, given via up to 3 catheters surgically placed in an intra-tumoral location. Concentration of gadoteridol will be 2 mM for all groups; both agents will be co-infused via the same catheters. Subjects in the two lowest dose groups will have tumor volumes of 1-4 cm3, the third dose group will be 2-5 cm3 and the highest dose group 2-6 cm3. Maximum total volume infused will be 1.0 ml for two lowest dose groups, 1.5 ml for the third dose group, and 2.0 ml for the highest dose group. RESULTS: Interim safety, efficacy, and imaging response results will be presented. Utilizing imaging software, we'll present the correlation of pre-infusion modeling of the drug distribution with post-infusion imaging and determination of the total volume of distribution (Vd) and the Vd to volume infused (Vi) ratio for each infusion. CONCLUSIONS: Image-guided distribution allows for real-time placement and adjustment of cannula for real time CED of MM-398 into the brains of patients with recurrent HGG.
机译：背景：高度脑胶质瘤（HGG）的化疗受到血脑屏障的限制。对流增强输送（CED）通过利用流体对流提高了化学疗法的输送，消除了穿越血脑屏障的挑战，同时最大程度地降低了全身毒性。纳米脂质体伊立替康（MM-398）的CED已在动物模型中进行了优化，显示出卓越的抗肿瘤活性。使用CED的一项进展是实时CED（RCD）的开发，它利用MRI在共流的造影剂的帮助下可视化CED的过程，从而监控向大脑的输送并采取纠正措施。方法：在R21的支持下，我们正在使用实时成像技术对复发性HGG患者进行Iso脂质体CED的I期研究。这是3 + 3剂量递增试验；剂量水平为20 mg，40 mg，60 mg和80 mg脂质体-伊立替康，通过最多3个通过外科手术置于肿瘤内位置的导管给予。所有组的gadoteridol浓度均为2 mM；两种药物将通过同一导管共同注入。两个最低剂量组的受试者的肿瘤体积为1-4 cm3，第三个剂量组的肿瘤体积为2-5 cm3，最高剂量组的肿瘤体积为2-6 cm3。两个最低剂量组的最大总输注量为1.0 ml，第三剂量组为1.5 ml，最高剂量组为2.0 ml。结果：将显示中期安全性，疗效和影像学反应结果。利用成像软件，我们将介绍药物分配的输液前建模与输液后成像的相关性，并确定每次输液的总分布体积（Vd）和输液的Vd与体积之比（Vi）。结论：图像引导分布允许实时放置和调整套管，以将MM-398实时CED实时送入HGG复发患者的大脑中。

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