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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2022

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.

Interventions

  • Drug: cisplatin
    • Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)

Clinical Trial Outcome Measures

Primary Measures

  • Dose limiting toxicity
    • Time Frame: 14 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Vermont
  • Collaborator
    • University of Vermont Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: C. Matthew Kinsey MD, MPH, Director, Interventional Pulmonary – University of Vermont
  • Overall Contact(s)
    • Stephanie Burns, (802) 656-8307, stephanie.burns@uvmhealth.org

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