Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
Graft-versus-Host Disease, Stomatitis
About this trial
This is an interventional treatment trial for Graft-versus-Host Disease focused on measuring Stomatitis, Oropharyngeal pain, TNF-alpha, Allogeneic hematopoietic stem cell transplant, Inflammation, Thalidomide, Oral chronic graft-versus-host disease
Eligibility Criteria
INCLUSION CRITERIA: Participating in HSCT or cGVHD protocols and willing to participate in this study concurrently; Diagnosed with oral cGVHD stomatitis confirmed by surgical biopsy results; Oral ulceration present Able to understand and sign protocol informed consent; Ages 18 to 80 years of age. EXCLUSION CRITERIA: Pregnant or lactating females; For the proof of concept study, females who are not surgically sterilized by means of hysterectomy or tubal ligation; For the main study, females of childbearing potential who do not agree to the use of two forms of highly effective contraception for at least four weeks prior, during, and for four weeks following the last dose of study drug; Sexually active males who do not agree to the use of a latex condom while receiving study drug and for four weeks following the last dose of study drug; Unwilling to follow precautions for use of thalidomide; Unable to demonstrate appropriate use of study medication; Concurrent use of non-protocol-related medications confounding assessment of the inflammatory response (antihistamines, non-steroidal anti-inflammatory drugs); Allergic reaction to thalidomide; Pre-existing oral infection, which might maximize the possibility of an infection or sepsis contributing to a drug-related adverse event; Unwilling or unable to forego concurrent treatment for mucosal lesions and/or related oral pain (including topical steroids, viscous lidocaine, topical anti-fungals); Requiring addition of new systemic therapy including thalidomide, steroids, or radiation therapy; Use of sedatives (including CNS depressants); Absolute neutrophil count (ANC) less than 750/mm(3)
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Thalidomide gel
Placebo
Thalidomide gel 20 mg applied topically 4 times daily for 4 weeks to a maximum of 3 target oral ulcers
Placebo gel with no Thalidomide applied topically 4 times daily for 4 weeks to a maximum of 3 target oral ulcers