Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant
Status: Recruiting
Phase: Phase 2
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01307462
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-417
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
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Vincent Ho, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Kimberly Phillips,
kimberly_phillips@dfci.harvard.edu
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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