Evaluation of Efficacy and Mechs of Topical Thalidomide for cGVHD Stomatitis

National Institute Of Nursing Research

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Abstract

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.