UCLA IRB # 06-04-104 "A PHASE I/II, DUAL-CENTER, OPEN-LABEL TRIAL OF THE SAFE

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 具体目标： 主要目标 本研究的I期部分将确定递增剂量的厄洛替尼与西罗莫司联合给药的MTD和DLT，这两种药物均以每日一次连续给药方案给予未接受EIAED的恶性胶质瘤成人患者; 本研究的II期部分将评估厄洛替尼和西罗莫司联合治疗在复发或复发时未接受手术的GBM/GS患者中的初步疗效（应答率[RR]、无进展生存期[PFS]和总生存期[OS]）（剂量扩展组; 评价对厄洛替尼和西罗莫司联合治疗应答的分子决定因素，尤其是EGFR突变（vIII突变体和其他vIII体细胞突变以及PTEN突变/缺失）的作用。

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. SPECIFIC AIMS: Primary Objectives The phase I component of this study will determine the MTD and DLT of escalating doses of erlotinib in combination with sirolimus, both administered on a continuous once daily dosing schedule to adult patients with malignant glioma, who are not receiving EIAED; The phase II component of this study will evaluate preliminary efficacy (response rate [RR], progression free survival [PFS] and overall survival [OS]) of erlotinib and sirolimus combination therapy in GBM/GS patients who are not undergoing surgery at the time of recurrence or relapse (dose expansion arm; Evaluate molecular determinants of response to this combination of erlotinib and sirolimus, especially the roles of the mutation of EGFR (vIII mutant and other somatic mutations of vIII and mutation/deletion of PTEN.