NCT04429204

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

Evaluation of Cryo-Immune Stimulation in Mesothelioma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of tissue
PROCEDURE	Cryosurgery	Undergo cryoablation

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-06-12
• Last updated: 2021-06-14

Locations

1 site across 1 country: United States