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Home > "E" Clinical Trials Conditions > Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis  Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
For Condition: Graft vs Host Disease
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: This study will test the effects of a thalidomide mouthwash in treating stomatitis in patients who have developed oral chronic graft-versus-host-disease (GVHD)-related stomatitis following allogeneic bone marrow transplantation (ABMT). Stomatitis is an inflammation of the lining of the throat and mouth that may lead to ulcers and pain in the mouth and throat. GVHD - a condition in which the donor cells "see" patient's cells as foreign and mount an immune response to them - may be caused by increased levels of a substance called TNF-alpha following ABMT. Thalidomide's anti-inflammatory effects may lower TNF-alpha levels and decrease chronic GVHD-related stomatitis and oral pain in these patients. Applying thalidomide directly to the mouth ulcers in mouthwash form rather than taking it as a pill may reduce the amount of drug that enters the blood stream and cause fewer side effects. Patients between 18 and 80 years of age who have received an ABMT and developed oral chronic GVHD-related stomatitis may be eligible for this study. Participants will be randomly assigned to receive thalidomide mouthwash or placebo (a mouth rinse with no thalidomide) to use four times a day. They will also undergo the following procedures before beginning medication, then once a week for 4 weeks, and then approximately 8 weeks after the first visit. - Interview about current medications and use of alcohol and cigarettes. - Mouth and throat pain ratings. - Quality of life questionnaire. - Dental examination. - Mouth photography to measure and record the response to treatment. - Saliva sampling to look for chemicals, including TNF-alpha. - Gentle swabbing of ulcers to obtain fluid for measuring chemicals such as TNF-alpha. - Small punch biopsy of the area near the ulcer to check for chemicals such as TNF-alpha and any virus or fungus that may be present in the ulcer. (The biopsy is repeated only at week 4 of the study.) - Blood sampling to monitor thalidomide and TNF-alpha levels. - Urine pregnancy test for women who can have children. (The pregnancy test is repeated at weeks 2, 4, and 8.)
Details: Oncology patients undergoing allogeneic bone marrow/peripheral blood stem cell transplant (ABMT) frequently experience an allo-immune condition termed graft-versus-host-disease (GVHD). The pathogenesis of GVHD derives from an immune attack mediated by donor T-cells recognizing antigens expressed on normal tissues of the patient. This condition occurs in ABMT rather than autologous BMT because of disparities in minor histocompability antigens between donor and recipient, inherited independently of HLA genes. GVHD may be conceptualized as a cytokine storm stemming from an outpouring of endogenous cytokines resulting in many tissue effects. Oral chronic GVHD (cGVHD), which is classically diagnosed as a late complication of ABMT occurring more than 100 days post transplant, presents with tissue atrophy and erythema, lichenoid changes (hyperkeratotic striae, patches, plaques, and papules) and pseudomembranous ulcerations typically occurring on the buccal and labial mucosa and the lateral tongue, mucoceles due to inflammation of minor salivary glands, and xerostomia. The ulcerative phase often leads to a cascade of negative sequelae including oropharyngeal pain, critical treatment alterations or cessation, diminished capacity for food intake, and decreased quality of life. We hypothesize that the mechanisms of tissue injury occurring at the mucosal level leading to cGVHD-related stomatitis are similar to other types of stomatitis, such as chemotherapy-related and aphthous stomatitis, and are therefore amenable to treatment with anti-inflammatory strategies. Optimal treatment strategies for cGVHD-related ulcerative stomatitis and related oropharyngeal pain have not been established. Therefore, there is a critical need to examine the pathogenesis of and to evaluate interventions for cGVHD-related ulcerative stomatitis and related acute oropharyngeal pain in the randomized controlled clinical trial (RCCT) setting to both advance the science of cancer treatment-related oral complications and to improve patient care. Therefore, the purpose of this RCCT is to elucidate the role of inflammation in GVHD-related ulcerative stomatitis by testing the efficacy of topical thalidomide on the resolution of cGVHD-related stomatitis and related oropharyngeal pain. The actions of thalidomide, which include inhibition of the release of tumor necrosis factor-alpha (TNF-alpha) and resultant alteration of the inflammatory cascade, may provide insight into the role of local mucosal inflammation in cGVHD-related stomatitis.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Allogeneic transplant patients who are enrolled in the participating NHLBI ABMT protocols, and are willing to participate in this study concurrently; Have a diagnosis of oral cGVHD as confirmed by surgical biopsy results; Able to understand and sign protocol consent; Ages 18 to 80 years. EXCLUSION CRITERIA: Pregnant or lactating females for main study; 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, antidepressants); 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 to forego concurrent treatment for mucosal lesions and/or related oral pain (including topical steroids, viscous lidocaine, topical anti0fungals, or mouthwashes); Requiring addition of new systemic therapy including thalidomide, steroids, or radiation therapy; Use of sedatives (including CNS depressants).
Total Enrollment: 132
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040069; 04-D-0069
Study Start Date: December 24, 2003
Record last reviewed: November 3, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075023
Other Graft Vs Host Disease Studies:
1. Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
2. Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
3. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
4. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
5. Potential of Transplanted Stem Cells to Mature into Salivary Gland and Cheek Cells
Related Studies:
Other Graft vs Host Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
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