Phase II Trial of PEG-Intron in Children with Diffuse Pontine Gliomas

这是一项II期研究，旨在评估在完成放射治疗后2-10周开始，每周小剂量的聚乙二醇腺苷对患有中枢神经系统肿瘤的儿童患者的疗效。与只接受放射治疗的历史对照组相比，试验的终点是两年的存活期。患者接受广泛的成像分析。这项试验的收益已经完成，正在对患者进行终点分析，并对生物样本进行评估。所有患者都能很好地耐受聚乙二醇-内含子疗法，没有直接归因于研究试剂的不良事件。包括两年存活率在内的总体研究结果已发表在《癌症》杂志上。我们发现，与最近完成的联合试验中的类似患者相比，接受PEG-Intron治疗的患者的中位进展时间为7个月，后者的中位进展时间为4-5个月。本次试验的应计项目和主要终点已完成。我们现在正在追踪我们的幸存病人。由于PI的离开，这个项目停止了。

This is a Phase II study designed to estimate the efficacy of weekly low-dose PEG-Intron in pediatric patients with CNS tumors, beginning 2-10 weeks after completion of radiation therapy. The endpoint of the trial is 2-year survival compared to historical controls who have received radiation alone. Patients undergo extensive imaging analysis. Accrual to this trial has been completed, patients are being followed for endpoint analyses, and biologic samples are being evaluated. All patients have tolerated the PEG-Intron therapy well, with no adverse events directly attributable to the study agent. Overall study results, including 2 year survival, have been published in the journal, Cancer. We showed that patients receiving PEG-Intron have a median time to progression of 7 months compared to similar patients on recently completed consortia trials, who have a median time to progression of 4-5 months. Accrual to this trial and the primary endpoint are complete. We are now following our surviving patient. This project halted due to the PI departure.