Intratumoral Cisplatin for Resectable NSCLC

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

PRIMARY OBJECTIVE:

To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol

DESIGN: 3+3 dose escalation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Collaborator: Johnson & Johnson
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Age ≥18 years.

• Eastern Cooperative Oncology Group performance status 0 or 1

• Patients must have adequate organ and marrow function as defined below:

• Leukocytes ≥3,000/microliter

• Platelets ≥100,000/microliter

• Total bilirubin ≤ institutional upper limit of normal (ULN)

• Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal

• Creatinine ≤ institutional ULN

• 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

• Have known or suspected clinical stage I-IIb NSCLC after computed tomography (CT) and/or positron emission tomography at time of enrollment

• Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter

• Agreement from a cardiothoracic surgeon, following review of past medical history, medications, pulmonary function testing, and CT scan that patient is likely to be a surgical candidate and that, after considering known possible adverse events, delivery of intratumoral cisplatin is unlikely to adversely affect surgical feasibility

• Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (per the determination of a trained, attending, cytopathologist). No research procedures will be performed if ROSE is non-diagnostic

• A CT scan of the chest (with or without contrast) within 1 month of the screening visit

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Use of an investigational agent within 30 days of the screening visit

• IV chemotherapy within the 30 days of the screening visit

• Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by University of Vermont Medical Center Policy

• History of prior radiation to the study lesion

• History of allergic reaction to cisplatin or its derivatives

• Patients with uncontrolled intercurrent illness

• Physician determination that patient would not be appropriate for study