Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311762
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
University of Vermont Medical Center
Information provided by (Responsible Party):
C. Matthew Kinsey MD, MPH, University of Vermont

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Age 18 years or above

Eastern Cooperative Oncology Group (ECOG) performance score 0-2

Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded based on 8.2 below).

Ability and willingness to provide informed consent

Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (informed consent will occur prior to the procedure). No research procedures will be performed if ROSE is non-diagnostic.

A CT scan of the chest (with or without contrast) within the prior 3 months.

The presence of an EBUS accessible target site. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS

Patients must have adequate organ and marrow function as defined below:

  • Leukocytes ≥3,000/mcL
  • Platelets ≥100,000/mcL
  • Total bilirubin ≤ institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) ≤ institutional ULN
  • Glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 via CKD EPI)

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria:

Use of an investigational agent in prior 30 days

Pregnancy/lactation

Treatment with 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

Patient not appropriate for the research study based on physician discretion

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Stephanie Burns (802) 656-8307 stephanie.burns@uvmhealth.org

Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: C. Matthew Kinsey, MD, MPH University of Vermont
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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