Status:
ACTIVE_NOT_RECRUITING
Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
University of Vermont Medical Center
Conditions:
Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 tech...
Eligibility Criteria
Inclusion
- 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
- 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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04311762
Start Date
February 1 2020
End Date
March 1 2029
Last Update
October 31 2025
Active Locations (1)
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1
University of Vermont
Burlington, Vermont, United States, 05405