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: 8350027
• 负责人: jane fall-dickson
• 金额: $ 17.01万
• 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/8350027
• 关键词: Age; Clinical; Clinical Services; Clinical Trials Data Monitoring Committees; Data; Data Analyses; Dental; Development; Drug Formulations; Effectiveness; Enrollment; Exudate; Fred Hutchinson Cancer Research Center; Gel; Inflammation; Inflammatory Response; Informed Consent; Institutes; Institutional Review Boards; Manuscripts; Monitor; Mouth Diseases; National Institute of Dental and Craniofacial Research; Nursing Research; Oral; Oral Diagnosis; Oral Ulcer; Oral mucous membrane structure; Oropharyngeal; Pain; Pathogenesis; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Placebos; Plasma; Play; Principal Investigator; Protocols documentation; Punch Biopsy; Randomized Controlled Clinical Trials; Research; 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; 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 at the Clinical Center, NIH. All subjects gave written informed consent. All data were collected, and study drug self-administered by subjects per protocol. Topical thalidomide and placebo was 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. Subject accrual was slower than anticipated with 10 subjects enrolled at the Clincal Center, NIH, over 2 years, and no subjects enrolled at the FHCRC over 1 year. Therefore, the study was closed to subject accrual with data analyses ongoing with National Institute of Dental and Cranifacial Research Institutional Review Board, NIH, approval. Data analysis examined preliminary findings of topical thalidomide gel on oral ulcerative chronic GVHD, levels of proinflammatory cytokines in saliva, oral ulcer exudate, and plasma, as well as oropharyngeal pain.

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月在NIH临床中心开始。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。受试者入组速度慢于预期，在NIH临床中心入组了10例受试者超过2年，在FHCRC入组的受试者超过1年。因此，该研究对受试者招募关闭，数据分析正在进行中，并获得美国国立牙科和颅面研究机构审查委员会（NIH）的批准。数据分析检查了局部沙利度胺凝胶对口腔溃疡性慢性GVHD的初步结果，唾液，口腔溃疡渗出液和血浆中促炎细胞因子的水平，以及口咽疼痛。