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

Brief Title

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

Official Title

Evaluation of Cryo-Immune Stimulation in Mesothelioma

Brief 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.

Study Type

Interventional

Primary Outcome

Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells

Condition

Mesothelioma

Intervention

Biospecimen Collection

Study Arms / Comparison Groups

 Basic science (cryoablation, tissue collection)

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

December 1, 2021

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2022

Eligibility Criteria

        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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Neema Jamshidi, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04429204

Organization ID

19-001175

Secondary IDs

NCI-2020-00640

Responsible Party

Sponsor

Study Sponsor

Jonsson Comprehensive Cancer Center

Study Sponsor

Neema Jamshidi, Principal Investigator, UCLA / Jonsson Comprehensive Cancer Center

Verification Date

December 2020