Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
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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.
Condition or disease
Lung Cancer Metastatic
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Eastern Cooperative Oncology Group (ECOG) performance score 0-2 Patients will have known or suspected Stage IV, metastatic, non-small cell lung cancer (NSCLC) after multidisciplinary review.
Use of an investigational agent in prior 30 days Pregnancy/lactation Treatment with IV 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