0514 GCC: A PHASE 1 STUDY OF SAHA IN COMBINATION WITH BORTEZOMIB IN RELAPSED

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I期临床试验，SAHA以递增剂量口服给药，并与硼替佐米每周两次静脉给药（第1和4、8和11天）相结合。每3周重复一次周期。本研究将确定该联合用药的安全剂量。研究开始时，3名患者将接受低剂量SAHA和硼替佐米治疗。如果这个剂量不会引起严重的副作用，它将随着新患者参与研究而逐渐增加。患者将在门诊接受最多8个周期（24周）的药物组合。仅在第1周期第4天进行8小时药代动力学评估。

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 trial of SAHA administered by mouth in increasing dose in combination with bortezomib given intravenously twice weekly (days 1 and 4,8 and 11). The cycles are repeated every 3 weeks. The study will establish the safe dose that can be given for this combination. At the beginning of the study 3 patients will be treated with a low dose of SAHA and Bortezomib. If this dose does not cause severe side effects it will gradually be increased as new patients take part in the study. Patients will take this combination of drugs for up to 8 cycles (24 weeks) on an outpatient basis. An 8 hour pharmacokinetic assessment will be done on day 4 of cycle 1 only.