Evaluation of Efficacy and Mechs of Topical Thalidomide for cGVHD Stomatitis

2007年6月26日，FDA最终批准了沙利度胺外用凝胶IND 76,793的使用。受试者招募于2007年11月开始，迄今为止在NIH临床中心招募了10名受试者。所有受试者均给予书面知情同意。收集所有数据，并研究受试者根据方案自行给药。局部沙利度胺和安慰剂由美国国立卫生研究院临床中心药物开发服务处制备。弗雷德哈钦森癌症研究中心（FHCRC），西雅图，华盛顿州。2008年8月，美国机构审查委员会批准了该议定书。在首席研究员和高级研究护士于2009年1月进行现场启动访问之后，FHCRC被添加为该方案的第二个临床站点。FHCRC的研究人员已经筛选了15名尚未入组的受试者。受试者招募继续通过Richard Childs医学博士，国家心脏、肺和血液研究所副研究员，国家癌症研究所每周在NIH临床中心赞助cGVHD诊所，并通过国家招募工作进行。

The FDA gave final clearance for use of thalidomide topical gel IND 76, 793, on June 26, 2007. Subject recruitment started in November 2007 with 10 subjects enrolled to date at the NIH Clinical Center. All subjects gave written informed consent. All data were collected, and study drug self-administered by subjects per protocol. Topical thalidomide and placebo is prepared by the Pharmaceutical Development Service, Clinical Center, NIH. The Fred Hutchinson Cancer Research Center's (FHCRC), Seattle, WA., institutional review board approved the protocol in August, 2008. Following the site initiation visit conducted by the principal investigator and senior research nurse in January 2009, the FHCRC was added as the second clinical site for this protocol. The investigators at the FHCRC have screened 15 subjects with no enrollment to date. Subject recruitment continues through Richard Childs, MD, Associate Investigator, National Heart, Lung, and Blood Institute, the weekly National Cancer Institute sponsored cGVHD Clinic at the NIH Clinical Center, and through the national recruitment effort.