The protocol site initation visit was completed in July 2006 at the National Cancer Institute sponsored Community Clinical Oncology Program located at the Cancer Centers of the Carolinas, Greenville, SC. Interrater reliability training was completed November 2, 2006. The CCOP recruited their first subject in 2007, and two patients have been recruited to date at this clinical site. All subjects gave written informed consent. All data were collected, and study drug was self administered by subject per protocol. Etanercept mouthwash/placebo is prepared by the Pharmaceutical Development Service, Clinical Center, NIH. All data and biological samples were received appropriately by the NINR Study Coordinating Center. The University of Maryland institutional review board approved this protocol in January 2009 for implementation through the Blood and Marrow Transplantation Program, University of Maryland Greenebaum Cancer Center. Following completion of the NIH mandated regulatory processes for this collaboration, the site initation visit and interrater relibility training will be conducted by the principal investigator and the research nurse, and subject recruitment will begin at this clinical site.
