Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma
Primary Purpose
Mesothelioma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Cryosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Mesothelioma
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
Sites / Locations
- UCLA / Jonsson Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Basic science (cryoablation, tissue collection)
Arm 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.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04429204
First Posted
June 10, 2020
Last Updated
June 10, 2021
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04429204
Brief Title
Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma
Official Title
Evaluation of Cryo-Immune Stimulation in Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study was not opened
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Basic science (cryoablation, tissue collection)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo collection of tissue
Intervention Type
Procedure
Intervention Name(s)
Cryosurgery
Other Intervention Name(s)
Ablation, Cryo, Cryoablation, cryosurgical ablation
Intervention Description
Undergo cryoablation
Primary Outcome Measure Information:
Title
Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells
Description
Will be tested by cryoablating a small region of tumor at the time of pleural biopsy.
Time Frame
After cryoablation of mesothelioma up to 1 year
Title
Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue
Description
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).
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neema Jamshidi
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma
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