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Trial record 1 of 1 for:
NCT01307462
Targeted Therapy of Bronchiolitis Obliterans Syndrome (FAM for BOS)
This study has been completed.
Sponsor:
Lee, Stephanie
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier:
NCT01307462
First received: March 1, 2011
Last updated: August 9, 2016
Last verified: August 2016
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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
| Condition | Intervention | Phase |
|---|---|---|
| Bronchiolitis Obliterans | Drug: fluticasone propionate Drug: montelukast sodium Drug: azithromycin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant |
Resource links provided by NLM:
Drug Information available for:
Fluticasone propionate
Azithromycin
Fluticasone
Montelukast sodium
Montelukast
Fluticasone furoate
U.S. FDA Resources
Further study details as provided by Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium:
Primary Outcome Measures:
- Treatment failure [ Time Frame: Within 3 months after initiation of study medications ]Must be confirmed by a second PFT 2 weeks after the first measurement. A sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1.
Secondary Outcome Measures:
- Incidence and types of National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0) [ Time Frame: Up to 6 months ]Grade 3-5 serious adverse events (SAEs) attributable to FAM; and the proportion of subjects who stop each drug during the study period.
- Changes in FEF 25-75, RV, DLCO, FEV1/FVC ratio and FEV1/SVC ratio [ Time Frame: Baseline to 6 months ]Will include FEV1 at month 6.
- Changes in blood molecular markers: IL8 (azithromycin), cysteinyl and LTB4 (monteleukast), and IL1B, TNF, and IL6, as well as neutrophil count (fluticasone) [ Time Frame: Baseline to 6 months ]
- Using the National Institute of Health (NIH) consensus criteria, the proportion of subjects with improvements in other chronic GVHD characteristics [ Time Frame: Up to 6 months ]Because of the relatively small sample sizes, results will be reported descriptively with 95% confidence intervals.
- Changes in HRQOL, exercise capacity, and symptoms compared to baseline [ Time Frame: Baseline to 6 months ]Using the following measurements: Short Form (SF) 36, Functional Assessment of Cancer Therapy (FACT), Human Activity Profile (HAP), chronic GVHD symptom scale for participants >= 18 years of age; Activity Scale for Kids (ASK) for participants < 18 years of age; six minute walk test.
- Total systemic steroid exposure [ Time Frame: Up to 6 months ]
| Enrollment: | 5 |
| Study Start Date: | June 2011 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (BOS therapy)
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
|
Drug: fluticasone propionate
Given inhaled PO
Other Names:
Drug: montelukast sodium
Given PO
Other Name: Singulair
Drug: azithromycin
Given PO
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if the combination treatment of FAM administered in post hematopoietic cell transplantation (HCT) recipients after the diagnosis of new onset bronchiolitis obliterans syndrome (BOS) can decrease the rate of treatment failure relative to an estimated historical rate of 40% using current therapies.
SECONDARY OBJECTIVES:
I. To confirm the safety profile of FAM.
II. To describe the effect on other standard pulmonary function test parameters: forced expiratory flow at 25%-75% of forced vital capacity (FVC) (FEF25-75), residual volume (RV), diffusion capacity of carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1)/FVC ratio and FEV1/slow vital capacity (SVC) ratio with FAM treatment.
III. To determine the change in molecular markers of inflammation and fibrosis in the blood with FAM treatment.
IV. To assess the impact of FAM on other chronic graft-versus-host disease (GVHD) manifestations.
V. To assess the impact of FAM on functional status, and health-related quality of life (HRQOL).
VI. To describe changes in steroid dosing.
OUTLINE:
Patients receive fluticasone propionate inhaled orally (PO) twice daily (BID), azithromycin PO 3 days a week, and montelukast sodium PO once daily (QD). Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 6 months.
Eligibility| Ages Eligible for Study: | 6 Years to 99 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307462
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307462
Locations
| United States, Arizona | |
| Mayo Clinic - Scottsdale | |
| Scottsdale, Arizona, United States, 85054 | |
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Maryland | |
| National Cancer Institute Experimental Transplantation & Immunology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Siteman Cancer Center at Washington University | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Lee, Stephanie
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Stephanie Lee | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| Study Chair: | Kirsten Williams | National Cancer Institute (NCI) |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lee, Stephanie, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT01307462 History of Changes |
| Other Study ID Numbers: |
2367.00 NCI-2011-00203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) U54CA163438 ( U.S. NIH Grant/Contract ) RDCRN 6503 ( Other Identifier: DMCC ) |
| Study First Received: | March 1, 2011 |
| Last Updated: | August 9, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | De-identified data are reported in aggregate. |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Fluticasone Montelukast Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017