Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma

Study Overview
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Brief Summary
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This trial evaluates if cryoablation will stimulate a local immune response by cluster of differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low survival rates. The information learned from this study may provide evidence as to whether there is a measurable, local immune response from cryoablation. Studying samples of mesothelioma tissue in the laboratory from patients who have undergone biopsy may help doctors learn more about the effects of cryoablation on cells. It may also help doctors understand how well patients respond to treatment.

Detailed Description
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PRIMARY OBJECTIVES: I. To evaluate the simple hypothesis that cryoablation of mesothelioma will promote local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells that will not be present in ablation naive regions of the tumors. II. To determine whether there is a preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue. OUTLINE: At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.

Official Title
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Evaluation of Cryo-Immune Stimulation in Mesothelioma

Conditions
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Mesothelioma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Cryosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults that have been identified at tumor board with high suspicion for mesothelioma and are anticipated to be surgical candidates, as determined/discussed at Mesothelioma Tumor Board Exclusion Criteria: Patients that have a questionable diagnosis of mesothelioma (i.e. there are other potentially more likely considerations in the differential diagnosis) or in patients that would not be expected to be good surgical candidates
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basic science (cryoablation, tissue collection)<br>At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected. | Procedure: Biospecimen Collection<br>* Undergo collection of tissue<br>Procedure: Cryosurgery<br>* Undergo cryoablation<br>* Other names: cryosurgical ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells | Will be tested by cryoablating a small region of tumor at the time of pleural biopsy. | After cryoablation of mesothelioma up to 1 year | 
| Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue | Subsequent fluorescence activated cell sorting for cluster of differentiation 4 positive (CD4+) and CD8+ markers will be performed to identify sub-populations of lymphocytes. The counts will be compared using a one-way paired t-test (two samples from each patient; ablated and non-ablated). The isolated cells will be frozen for potential subsequent use (if the hypothesis for the study is true then subsequent profiling of the cells will be performed, such whole exome sequencing (ribonucleic acid-sequencing) and metabolomic profiling). | Up to 1 year |