An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
4 Years
N/A
Both
Oral Chronic Graft-versus-host Disease
Trial Information
An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate and characterize the clinical efficacy of topical steroid and topical tacrolimus therapies for the treatment of oral cGHVD.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Nathaniel Treister, DMD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brigham and Women's Hospital
Authority:
United States: Institutional Review Board
Study ID:
08-027
NCT ID:
NCT00686855
Start Date:
August 2008
Completion Date:
March 2013
Related Keywords:
- Oral Chronic Graft-Versus-Host Disease
- tacrolimus
- dexamethasone
- oral rinse
- Graft vs Host Disease
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Children's Hospital Boston | Boston, Massachusetts 02115 |
| Beth-Israel Deaconess Medical Center | Boston, Massachusetts |
