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

Lung Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04311762
• Other study ID #: 00000613
• Status: Recruiting
• Phase: Phase 1
• Start date: February 26, 2020
• Est. completion date: March 2023

Study information

• Verified date: May 2022
• Source: University of Vermont
• Contact: Stephanie Burns
• Phone: (802) 656-8307
• Email: stephanie.burns[@]uvmhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Metastatic
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity		14 days