Stage I Lung Cancer, Stage II Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECryosurgery
Undergo cryodevitalization
PROCEDURERobotic Bronchoscopy
Undergo standard of care robotic bronchoscopy with biopsy
PROCEDUREBronchoscopy with Biopsy
Undergo standard of care robotic bronchoscopy with biopsy
PROCEDUREResection
Undergo standard of care surgical resection
PROCEDUREChest Radiography
Undergo chest x-ray
PROCEDUREComputed Tomography
Undergo Computed Tomography
PROCEDUREBiospecimen Collection
Undergo tissue sample collection
OTHERElectronic Health Record Review
Ancillary studies
Sponsors
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Swim Across America
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection * Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs * Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) \> 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board * Age \> 18 years old
Exclusion criteria
* Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \& laryngeal nerves), or are \< 10 mm from the pleura * Patients with an expected survival less than 6 months * Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways * Patients with medically uncorrectable coagulopathy: abnormal platelet count \< 100 × 10\^9/L or an international normalized ratio \> 1.5 * Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg) * Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors * Patients with medical comorbidities deemed high-risk for surgical resection * Pregnant women * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose for cryodevitalization cycle duration | At time of surgery | 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. |
| Feasibility of bronchoscopically delivered cryodevitalization | At time of surgery | Proportion of procedures that can be safely completed with full dose delivered |
| Incidence of adverse events | Up to 7 days post-cryosurgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic response | At time of surgical resection | 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. |
| Incidence of adverse events | From day 8 post-cryosurgery to surgical resection | 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. |
Countries
United States
Contacts
CONTACTVanderbilt-Ingram Services for Timely Access
PRINCIPAL_INVESTIGATORFabien Maldonado, MD
Vanderbilt University/Ingram Cancer Center
Outcome results
None listed