Clinical trial NCT04311762: Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
Official title: Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lung Cancer Metastatic
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: University of Vermont Medical Center
First posted: 2020-03-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS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

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: C. Matthew Kinsey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: