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

Jonsson Comprehensive Cancer Center

Status: Withdrawn

Conditions: Mesothelioma

Treatments: Procedure: Cryosurgery; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04429204

NCI-2020-00640 (Registry Identifier)

19-001175 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Basic science (cryoablation, tissue collection)

Experimental group

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Procedure: Cryosurgery