NCT02066103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

February 13, 2014

Last Update Submit

April 18, 2018

Conditions

Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Airway patency improvements

    6 weeks

  • Quality of Life

    12 weeks

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: Paclitaxel

Interventions

PaclitaxelDRUG
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Raleigh, North Carolina, United States

Location

Related Publications (1)

  • 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.

    PMID: 30776363DERIVED

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 19, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

US(3)