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| ID | Type | Description | Link |
|---|---|---|---|
| 5R42CA141907-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Airway patency improvements | 6 weeks | |
| Quality of Life | 12 weeks |
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Inclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| The University of North Carolina at Chapel Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30776363 | Derived | 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. |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Duke University | Raleigh | North Carolina | United States |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |