UCLA IRB #05-12-061 "A PHASE I STUDY OF VORINOSTAT (SUBEROYLANILIDE HYDROXAMI

加州大学洛杉矶分校IRB

• 批准号: 7951558
• 负责人: TIMOTHY CLOUGHESY
• 金额: $ 0.22万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951558
• 关键词: Cells; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Drug Kinetics; Funding; Grant; Histone Acetylation; Institution; Malignant Glioma; Maximum Tolerated Dose; Measures; Mononuclear; Patients; Peripheral; Phase I Clinical Trials; Research; Research Ethics Committees; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; Vorinostat; molecular phenotype; response; temozolomide; tumor

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 ¿ To define the maximum tolerated dose (MTD) of vorinostat in combination with temozolomide in patients with malignant gliomas. ¿ To define the maximum tolerated dose (MTD) of vorinostat in combination with temozolomide in patients with malignant gliomas. ¿ To characterize the safety profile of vorinostat (SAHA) in combination with temozolomide. Secondary Objectives ¿ To characterize the pharmacokinetics of vorinostat (SAHA) in combination with temozolomide. ¿ To determine efficacy of vorinostat (SAHA) in combination with temozolomide as measured by objective response. Exploratory Objectives ¿ To explore the association of response to treatment to the molecular phenotype of the tumor. ¿ To assess the effects of vorinostat (SAHA) on histone acetylation status in peripheral mononuclear cells.

这个子项目是许多利用 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 ¿ 确定伏立诺他联合替莫唑胺治疗恶性胶质瘤患者的最大耐受剂量（MTD）。 ¿ 确定伏立诺他联合替莫唑胺治疗恶性胶质瘤患者的最大耐受剂量（MTD）。 ¿ 描述伏立诺他（SAHA）联合替莫唑胺的安全性特征。 次要目的 ¿ 描述伏立诺他（SAHA）联合替莫唑胺的药代动力学特征。 ¿ 通过客观缓解测定伏立诺他（SAHA）联合替莫唑胺的疗效。 探索性目的 ¿ 探索治疗反应与肿瘤分子表型的相关性。 ¿ 评估伏立诺他（SAHA）对外周血单个核细胞中组蛋白乙酰化状态的影响。