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

NCT00686855 | Completed Phase 2 Results DMC

• 1 other identifier: 08-027
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief 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)

Conditions

Oral Chronic Graft-versus-host Disease

Keywords

tacrolimus; dexamethasone; oral rinse

Outcome Measures

Primary Outcomes (1)

• The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.

  Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.

  Participants were assessed at Baseline and 4 weeks after start of therapy

Study Arms (2)

Tacrolimus

EXPERIMENTAL

Tacrolimus Arm Closed to Accrual as of January 2012

Drug: Tacrolimus

Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone

Interventions

Tacrolimus DRUG

Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks

Tacrolimus

Dexamethasone DRUG

Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks

Dexamethasone

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients already on topical steroid or tacrolimus therapies

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Boston Children's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Tacrolimus; Dexamethasone

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Nathaniel S. Treister, DMD, DMSc
• Organization: Dana-Farber Cancer Institute

ntreister@partners.org

617-632-2806

Study Officials

• Nathaniel Treister, DMD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 20, 2014
• Results First Posted: February 19, 2014

Record last verified: 2014-02

Locations

US (5)