Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients

Study Overview
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Brief Summary
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Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed. This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.

Official Title
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Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients

Conditions
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Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Life expectancy of at least 12 weeks Adequate bone marrow, liver, and renal function Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer Measurable disease with obstruction into the airway Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer Patients undergo recanalization procedure of tumor during bronchoscopy Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization Exclusion Criteria: Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study Uncontrolled infection Presence or recent history of any systemic disorder or conditions, such as: uncontrolled hypertension type 1 diabetes severe pulmonary hypertension acute kidney injury stroke (within the last 6 month) myocardial infarction (within the last 3 months) Individuals with neurological, mental or psychiatric disorders Concurrent participation in another study involving investigational drugs or investigational medical devices Other (non-cancer) disease not stabilized within 1 month before the Screening Visit Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation Any intraoperative complications that per the investigator's judgment increase the risk to the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment safety | Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs) | 12 weeks | 
| Technical success | Device deployment and infusion success | procedure day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway patency improvements |  | 6 weeks | 
| Quality of Life |  | 12 weeks |