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Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer

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ClinicalTrials.gov Identifier: NCT04311762
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
University of Vermont Medical Center
Information provided by (Responsible Party):
C. Matthew Kinsey MD, MPH, University of Vermont

Study Description
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Brief Summary:
The goal of the study is to identify the maximum tolerated dose of endobronchial ultrasound-guided transbronchial injection (EBUS-TBNI) of cisplatin for Stage IV lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Drug: cisplatin Phase 1

Detailed Description:
Multiple studies have demonstrated feasibility and safety of delivering cisplatin directly into lung tumors using endobronchial ultrasound guided-transbronchial needle injection (EBUS-TBNI). This technique relies on the use of a bronchoscope with an integrated ultrasound transducer allowing real-time visualization of, and delivery of cisplatin into, tumors lying in proximity to the central airways. Prior work has utilized this technique to treat loco regional recurrence in a previously radiated field. The goal of the current study is to identify the initial dose for intratumoral cisplatin.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Cisplatin

Arms and Interventions
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Intervention Details:
  • Drug: cisplatin
    Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)
    Other Name: Platinol

Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicity [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance score 0-2 Patients will have known or suspected Stage IV, metastatic, non-small cell lung cancer (NSCLC) after multidisciplinary review.

Exclusion Criteria:

Use of an investigational agent in prior 30 days Pregnancy/lactation Treatment with IV cytotoxic chemotherapy within the past 30 days Prior (within the last 12 months) or ongoing radiation treatment to the study NSCLC Allergy to cisplatin or its derivatives

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311762


Contacts
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Contact: Stephanie Burns (802) 656-8307 stephanie.burns@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Stephanie Burns    802-656-8307    stephanie.burns@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
University of Vermont Medical Center
More Information
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Responsible Party: C. Matthew Kinsey MD, MPH, Director, Interventional Pulmonary, University of Vermont
ClinicalTrials.gov Identifier: NCT04311762    
Other Study ID Numbers: 00000613
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Cisplatin
Antineoplastic Agents