Overview

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

Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Vermont
Collaborator:
University of Vermont Medical Center
Treatments:
Cisplatin
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metastatic sites (including when a lymph node station has been replaced by metastatic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