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

点击翻译按钮获取中文摘要

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.