Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
This study has been completed.
Sponsor:
Brigham and Women's Hospital
Collaborators:
Dana-Farber Cancer Institute
Children's Hospital Boston
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00686855
First received: May 27, 2008
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)
| Condition | Intervention | Phase |
|---|---|---|
|
Oral Chronic Graft-versus-host Disease |
Drug: Tacrolimus Drug: Dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Tacrolimus
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To evaluate and characterize the clinical efficacy of topical steroid and topical tacrolimus therapies for the treatment of oral cGHVD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 46 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tacrolimus
Tacrolimus Arm Closed to Accrual as of January 2012
|
Drug: Tacrolimus
Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
|
| Experimental: Dexamethasone |
Drug: Dexamethasone
Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
|
Detailed Description:
- Because no one knows which study option is best, participants will be "randomized" into one of two study groups: topical dexamethasone or topical tacrolimus.
- Participants will take the medication by mouth rinse four times a day for 5 minutes at a time. After rinsing they will spit out the medication and will not be able to eat or drink for 15 minutes.
- Participants will also take anti-fungal medication (fluconazole) orally once a week.
- After two weeks on study treatment, participants will have a blood drawn to monitor tacrolimus levels.
- After the final treatment (4 weeks), participants will have the following tests and procedures: clinical examination; questionnaire; blood tests; oral culture; optional tissue biopsy.
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with oral chronic graft-versus-host disease
- Patients 4 years of age or older
- Stable cGVHD medication regimen for the four weeks prior to study enrollment
Exclusion Criteria:
- Patients already on topical steroid or tacrolimus therapies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686855
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth-Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States | |
Sponsors and Collaborators
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Children's Hospital Boston
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
| Principal Investigator: | Nathaniel Treister, DMD | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Nathaniel S. Treister, DMD, DMSc, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00686855 History of Changes |
| Other Study ID Numbers: | 08-027 |
| Study First Received: | May 27, 2008 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
tacrolimus dexamethasone oral rinse |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Tacrolimus Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013