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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Interventions

  • Drug: Paclitaxel

Arms, Groups and Cohorts

  • Experimental: Treatment

Clinical Trial Outcome Measures

Primary Measures

  • Treatment safety
    • Time Frame: 12 weeks
    • Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
  • Technical success
    • Time Frame: procedure day
    • Device deployment and infusion success

Secondary Measures

  • Airway patency improvements
    • Time Frame: 6 weeks
  • Quality of Life
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mercator MedSystems, Inc.
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.