Targeted Therapy of Bronchiolitis Obliterans Syndrome

Not Recruiting

Trial ID: NCT01307462

Purpose

This phase II trial studies 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

Official Title

Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant

Stanford Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - Diagnosis of BOS after HCT within the 6 months before study enrollment; for this
   study, BOS is defined as:

      - Forced expiratory volume in 1 second (FEV1) < 75% of the predicted normal and
      FEV1 to slow or inspiratory vital capacity ratio (FEV1/SVC or FEV1/IVC) =< 0.7,
      both measured before and after administration of bronchodilator OR

      - Pathologic diagnosis of BOS demonstrated by lung biopsy

   - The baseline absolute FEV1 must be >= 10% lower than the pre-transplant absolute FEV1
   as defined by the pre-transplant FEV1 minus the baseline FEV1, both measured before
   administration of a bronchodilator

   - Participant (or parent/guardian) has the ability to understand and willingness to sign
   a written consent document

Exclusion Criteria:

   - Recurrent or progressive malignancy requiring anticancer treatment

   - Known history of allergy to or intolerance of montelukast, zafirlukast, azithromycin,
   erythromycin, or clarithromycin

   - Pregnancy or nursing; all females of childbearing potential must have a negative serum
   or urine pregnancy test < 7 days before study drug administration

   - Transaminases > 5 X upper limit of normal (ULN)

   - Total bilirubin > 3 X ULN

   - Chronic treatment with any inhaled steroid for > 1 month in the past three months

   - Treatment with montelukast or zafirlukast for > 1 month during the past three months

   - Treatment with prednisone at > 1.2 mg/kg/day (or equivalent steroid)

   - Treatment with rifampin or phenobarbital, aspirin at doses > 325 mg/day, or ibuprofen
   at doses > 1200 mg/day

   - Treatment with any Food and Drug Administration (FDA) non approved study medication
   within the past 4 weeks; off-label treatment with an FDA-approved medication is
   allowed

   - Chronic oxygen therapy

   - Evidence of any viral, bacterial or fungal infection involving the lung and not
   responding to appropriate treatment

   - Clinical asthma (variable and recurring symptoms of airflow obstruction and bronchial
   hyper-responsiveness)

   - Any condition that, in the opinion of the enrolling investigator, would interfere with
   the subject's ability to comply with the study requirements

   - Uncontrolled substance abuse or psychiatric disorder

   - Inability to perform pulmonary function tests (PFT) reliably, as determined by the
   enrolling investigator or PFT lab

   - Life expectancy < 6 months at the time of enrollment as judged by the enrolling
   investigator

   - Baseline post-bronchodilator FEV1 < 20% of predicted normal before or after albuterol

Intervention(s):

drug: Azithromycin

drug: fluticasone propionate

drug: montelukast sodium

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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