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

Mesothelioma Clinical Trial

Official title:

Evaluation of Cryo-Immune Stimulation in Mesothelioma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04429204
• Other study ID #: 19-001175
• Secondary ID: NCI-2020-0064019
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2021
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of tissue
• Cryosurgery
Undergo cryoablation

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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