Status:
TERMINATED
Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
Lead Sponsor:
National Institute of Nursing Research (NINR)
Collaborating Sponsors:
Fred Hutchinson Cancer Center
Conditions:
Graft-versus-Host Disease
Stomatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study was designed to be conducted in 2 parts. The first part is a pilot study to test the effects of topical thalidomide gel 20mg applied to up to 3 oral ulcers in patients who have developed or...
Detailed Description
Oncology patients undergoing allogeneic bone marrow/peripheral blood stem cell transplant (HSCT) frequently experience an allo-immune condition termed graft-versus-host-disease (GVHD). The pathogenesi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00075023
Start Date
December 1 2003
End Date
April 1 2010
Last Update
November 4 2015
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 28104