A PHASE I STUDY OF BORTEZOMIB AND TEMOZOLOMIDE IN PATIENTS WITH REFRACTORY SOLID

硼替佐米和替莫唑胺治疗难治性固体患者的 I 期研究

• 批准号: 7982063
• 负责人: JANA PORTNOW
• 金额: $ 7.77万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982063
• 关键词: Anticonvulsants; Bortezomib; Brain Neoplasms; Central Nervous System Lymphoma; Cerebrospinal Fluid; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose-Limiting; Drug Kinetics; Enzymes; Funding; Glioma; Grant; Hepatic; In complete remission; Institution; Maximum Tolerated Dose; Measures; Metastatic malignant neoplasm to brain; Metastatic/Recurrent; Neuraxis; Patients; Pharmaceutical Preparations; Phase I Clinical Trials; Primary Brain Neoplasms; Recurrence; Refractory; Research; Research Personnel; Resources; Solid; Solid Neoplasm; Source; Toxic effect; United States National Institutes of Health; Unresectable; palliative; partial response; temozolomide

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. This is a Phase I study of bortezomib and temozolomide in subjects with a recurrent primary brain tumor (including primary CNS lymphoma) or recurrent brain metastases or confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective. The objectives of this study are: 1.1 To determine the dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) for the combination of bortezomib and temozolomide in patients with recurrent high-grade gliomas, recurrent metastatic brain tumors or other refractory solid tumors. 1.2 To evaluate the pharmacokinetics of bortezomib in patients taking hepatic enzyme-inducing anticonvulsants (Group A) and in those who are not (Group B). 1.3 To assess whether bortezomib crosses into the central nervous system by measuring drug levels in the cerebrospinal fluid. 1.4 To describe the proportion of study patients treated with bortezomib and temozolomide who obtain a confirmed complete response or partial response.

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。 这是一项硼替佐米和替莫唑胺在复发性原发性脑肿瘤（包括原发性CNS淋巴瘤）或复发性脑转移瘤或确诊的转移性或不可切除的实体瘤受试者中的I期研究，对于这些受试者，标准治愈或姑息措施不存在或不再有效。 本研究的目的是： 1.1确定硼替佐米和替莫唑胺联合治疗复发性高级别胶质瘤、复发性转移性脑肿瘤或其他难治性实体瘤患者的剂量限制性毒性（DLT）和最大耐受剂量（MTD）。 1.2评价硼替佐米在服用肝酶诱导抗惊厥药的患者（A组）和未服用肝酶诱导抗惊厥药的患者（B组）中的药代动力学。 1.3通过测量脑脊液中的药物水平来评估硼替佐米是否进入中枢神经系统。 1.4描述接受硼替佐米和替莫唑胺治疗的研究患者获得确认的完全缓解或部分缓解的比例。