Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oral Chronic Graft-versus-host Disease
Intervention: Tacrolimus (Drug); Dexamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s): Nathaniel Treister, DMD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Summary
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)
Clinical Details
Official title: An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
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
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Beth-Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Children's Hospital Boston, Boston, Massachusetts 02115, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: August 2008
Last updated: February 24, 2014
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