Clinical trial NCT02066103: Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Official title: Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
Lead sponsor: Mercator MedSystems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment safety
timeFrame: 12 weeks
measure: Technical success
timeFrame: procedure day
Secondary outcomes:
measure: Airway patency improvements
timeFrame: 6 weeks
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
citation: Yarmus L, Mallow C, Akulian J, Lin CT, Ettinger D, Hales R, Voong KR, Lee H, Feller-Kopman D, Semaan R, Seward K, Wahidi MM. Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy. Chest. 2019 Sep;156(3):562-570. doi: 10.1016/j.chest.2019.02.006. Epub 2019 Feb 15.