The data and safety monitoring plan for the study was approved by the NINR Data and Safety Monitoring Board. The FDA gave final clearance for use of thalidomide topical gel IND 76, 793, on June 26, 2007. Recruitment started in November 2007 with 8 subjects recruited to date at the NIH Clinical Center. All subjects gave written informed consent. All data was collected, and study drug self-administered by subject per protocol. Subjects recruitment continues through Richard Childs, MD, Associate Investigator, National Heart, Lung, and Blood Institute, the weekly National Cancer Institute (NCI) sponsored cGVHD Clinic at the NIH Clinical Center, and through a national recruitment effort. Topical thalidomide/placebo is prepared by the Pharmaceutical Development Service, Clinical Center, NIH.
