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Bone Marrow Transplant

Targeted Therapy of Bronchiolitis Obliterans Syndrome (2367)
Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant
Status Conditions Phase Study ID
Closed Chronic Graft Versus Host Disease (cGVHD) Phase II 2367
NCT01307462
Summary

Purpose This phase II trial studies show how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans.


Investigator
Paul Martin, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

  Ages Eligible for Study:     6 Years and older
Genders Eligible for Study:     Both
  Accepts Healthy Volunteers:     No

  • New diagnosis of BOS after HCT within 3 months of study enrollment
  • The baseline absolute FEV1 must be >= 10% lower than the pre-transplant FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1
  • Life expectancy > 6 months at the time of enrollment as judged by the enrolling investigator
  • All females of childbearing potential must have a negative serum or urine pregnancy test =< 7 days before study drug administration
  • Subject (or parent/guardian) has the ability to understand and willingness to sign a written consent document
Exclusions (conditions that would prevent participation in this study)
  • Patients with recurrent malignancy or disease progression requiring anticancer therapy
  • Known history of allergy to montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin
  • Pregnant females or nursing mothers
  • Transaminases > 5 X upper limit of normal (ULN)
  • Total bilirubin > 3 X ULN
  • Patients currently on daily inhaled steroid (with any inhaled steroid equivalent to fluticasone) for > 1 month preceding enrollment
  • Patients currently on montelukast for > 1 month preceding enrollment
  • Patients currently on chronic dosing of azithromycin (>= 3 x/week) for > 1 month preceding enrollment; patients that have taken a Z-pak or other macrolides to treat infection are eligible
  • Patients requiring > 1.2 mg/kg/day of prednisone (or equivalent steroid)
  • Receipt of any non-Food and Drug Administration (FDA) approved study medication within the last 4 weeks (this does not apply to use of FDA-approved drugs for an off-label indication)
  • Evidence of any viral, bacterial or fungal infection not responding to appropriate treatment
  • Patients with clinical asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness)
  • Patient with any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements
  • Patients on long-term oxygen therapy
  • Patients with uncontrolled substance abuse or psychiatric disorder
  • Patients who are deemed (by the local principal investigator [PI] or the pulmonary function test [PFT] lab) unable to reliably perform pulmonary function tests
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.