Clobetasol for Oral Graft-Versus-Host Disease
Condition: Oral Chronic Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Clobetasol Oral Rinse; Placebo oral rinse
Intervention description: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.; Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.
Intervention MeSH terms: Clobetasol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 12 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: cGVHD; Oral cGVHD; Topical; Oral Rinse; Clobetasol; Oral Graft-Versus-Host Disease; GVHD

Summary:

      Background:

      - Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow
      transplants. It is the result of the donor cells trying to attack the recipients body.
      Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and
      painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause
      side effects when given as pills or injections. Steroids given in a cream or rinse form,
      applied directly to the site of the symptoms, can have fewer side effects. However, their
      effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a
      steroid called clobetasol can be used as a mouth rinse to treat oral GHVD.

      Objectives:

      - To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host
      disease.

      Eligibility:

      - Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol.

      Design:

        -  Participants will be screened with a physical exam and medical history. Blood and urine
           samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and
           other tests before starting the study drug.

        -  Participants will be separated into two groups. One group will receive clobetasol; the
           other will have a placebo liquid.

        -  Participants will rinse their mouths with the study liquid three times a day after meals
           for 2 weeks.

        -  After 2 weeks, participants will have another study visit with blood tests and other
           exams.

        -  After the study visit, all participants will start to use the clobetasol rinse. Those
           who originally had clobetasol will use the rinse for another 2 weeks. Those who
           originally had a placebo will use the rinse for 4 weeks.

        -  Participants will have a follow-up exam after the end of treatment....
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Age: 12 years 99 years.

          -  Diagnosis: clinically significant oral chronic graft versus host disease (cGVHD) after
             allogeneic hematopoietic stem cell transplant (HSCT) with severity score of at least 2
             on erythema subset and/or at least 1 on ulceration subset and a composite score
             greater than or equal to 20 of the Oral Mucositis Rating Scale (OMRS) scale confirmed
             by the principal investigator (PI), clinical study chair (CSC), or lead associate
             investigator (LAI).

          -  Hematologic Function: Patients must have a platelet count greater than or equal to
             20,000/microL at the time of the initial evaluation.

          -  Informed Consent: All patients or their legal representative (for patients <18 years
             old) must sign an institutional review board (IRB) approved informed consent document
             (cGVHD natural history protocol 04-C-0281 or any National Cancer Institute (NCI)
             protocol allowing for screening procedures) prior to performing studies to determine
             patient eligibility. After confirmation of patient eligibility all patients or their
             legal representative must sign the protocol specific informed consent. For pediatric
             patients age appropriate assent will be obtained in accordance with National
             Institutes of Health (NIH) guidelines.

          -  Patients must be able to rinse and expectorate study medication rather than swallow
             it. Female patients must be willing to practice birth control (including abstinence)
             during and for two months after treatment, if of childbearing potential.

          -  Patients must have the ability and willingness to come to Clinical Center for
             bi-weekly follow-up appointments.

          -  No change in systemic immunosuppressive therapy (type or intensity level) within 2
             weeks prior to enrollment.

          -  A 7-day washout period is required if patients are currently using another oral
             topical treatment for mouth lesions. Patients currently using clobetasol oral topical
             treatment are not eligible for this study.

        EXCLUSION CRITERIA:

          -  Documented hypersensitivity to clobetasol.

          -  Use of clobetasol ointment intra-orally at any time during the last 6-month period.

          -  Pregnant or breast-feeding females due to possible toxicity to the fetus or infant.

          -  Inability to understand the investigational nature of the study to provide informed
             consent.

          -  Patients who, for medical or other reasons, are unable to comply with the study
             procedures.