This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.
PRIMARY OBJECTIVE: I. To identify the maximum tolerated dose (MTD) for cryodevitalization cycle duration. OUTLINE: This is a dose-escalation study. Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3, 5, or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study. Patients then undergo standard of care surgical resection on study. Patients also undergo a chest radiography (x-ray) on study as well as computed tomography (CT) and tissue sample collection throughout the study. After completion of study treatment, patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Undergo cryodevitalization
Undergo standard of care robotic bronchoscopy with biopsy
Undergo standard of care robotic bronchoscopy with biopsy
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Maximum tolerated dose for cryodevitalization cycle duration
Will implement a modified Toxicity Probability Interval design. Each dose will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.
Time frame: At time of surgery
Feasibility of bronchoscopically delivered cryodevitalization
Proportion of procedures that can be safely completed with full dose delivered
Time frame: At time of surgery
Incidence of adverse events
Will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.
Time frame: Up to 7 days post-cryosurgery
Pathologic response
Pathologic response will be assessed comparing the confirmed devitalization zone determined by intraprocedural cone-beam computed tomography imaging (percent tumor treated by cryodevitalization) and remaining tumor viability by histopathologic examination of resected specimens.
Time frame: At time of surgical resection
Incidence of adverse events
Will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.
Time frame: From day 8 post-cryosurgery to surgical resection
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Undergo standard of care surgical resection
Undergo chest x-ray
Undergo Computed Tomography
Undergo tissue sample collection
Ancillary studies