Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Status:	Completed
Conditions:	Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	Any
Updated:	2/4/2013
Start Date:	August 2008
End Date:	January 2013
Contact:	Nathaniel Treister, DMD
Phone:	617-632-2806

An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

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)

- 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

We found this trial at

sites

Dana-Farber Cancer Institute

450 Brookline Ave
Boston, Massachusetts 2215

617-632-3000