Evaluation of Efficacy and Mechs of Topical Thalidomide for cGVHD Stomatitis

外用沙利度胺治疗cGVHD口腔炎的疗效及机制评价

• 批准号: 7969488
• 负责人: jane fall-dickson
• 金额: $ 16.67万
• 依托单位: NATIONAL INSTITUTE OF NURSING RESEARCH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7969488
• 关键词: Age; Clinic; Clinical; Clinical Services; Clinical Trials Data Monitoring Committees; Data; Development; Drug Formulations; Effectiveness; Enrollment; Exudate; Fred Hutchinson Cancer Research Center; Gel; Gene Expression; Inflammation; Inflammatory Response; Informed Consent; Measures; Monitor; Mouth Diseases; Mouthwash; National Cancer Institute; National Heart, Lung, and Blood Institute; Nursing Research; Oral; Oral Diagnosis; Oral Ulcer; Oral mucous membrane structure; Pathogenesis; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Placebos; Plasma; Play; Principal Investigator; Protocols documentation; Punch Biopsy; Randomized Controlled Clinical Trials; Research Ethics Committees; Research Personnel; Role; Safety; Saliva; Self-Administered; Site; Stomatitis; Testing; Thalidomide; Topical application; Tumor Necrosis Factor-alpha; United States National Institutes of Health; Visit; Writing; chronic graft versus host disease; clinical efficacy; clinical research site; cytokine; efficacy evaluation; human TNF protein; inclusion criteria; novel; oral condition; tool; treatment strategy

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.

FDA于2007年6月26日最终批准使用沙利度胺外用凝胶IND 76，793。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例受试者。所有受试者均提供了书面知情同意书。收集所有数据，并由受试者按照方案自行给予研究药物。局部沙利度胺和安慰剂由NIH临床中心药物开发服务处制备。位于华盛顿州西雅图的弗雷德哈钦森癌症研究中心（FHCRC），机构审查委员会于2008年8月批准了该方案。在主要研究者和高级研究护士于2009年1月进行研究中心启动访视后，FHCRC被添加为本方案的第二个临床研究中心。FHCRC的研究人员已经筛选了15名受试者，迄今为止还没有招募。受试者招募继续通过Richard查尔兹，MD，国家心肺血液研究所副研究员，国家癌症研究所每周赞助的NIH临床中心的cGVHD诊所，并通过国家招募工作。