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.
| Mitchell, Sandra A; Jacobsohn, David; Thormann Powers, Kimberly E et al. (2011) A multicenter pilot evaluation of the National Institutes of Health chronic graft-versus-host disease (cGVHD) therapeutic response measures: feasibility, interrater reliability, and minimum detectable change. Biol Blood Marrow Transplant 17:1619-29 |
| Fall-Dickson, Jane M; Mitchell, Sandra A; Marden, Susan et al. (2010) Oral symptom intensity, health-related quality of life, and correlative salivary cytokines in adult survivors of hematopoietic stem cell transplantation with oral chronic graft-versus-host disease. Biol Blood Marrow Transplant 16:948-956 |
