Intratumoral Cisplatin for Resectable NSCLC (NCT04809103) | Clinical Trial Compass
CompletedPhase 1
Intratumoral Cisplatin for Resectable NSCLC
United States6 participantsStarted 2021-03-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* …