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.
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