Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429204
Recruitment Status : Withdrawn (The study was not opened)
First Posted : June 12, 2020
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Mesothelioma Procedure: Biospecimen Collection Procedure: Cryosurgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Cryo-Immune Stimulation in Mesothelioma
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Basic science (cryoablation, tissue collection)
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.
Procedure: Biospecimen Collection
Undergo collection of tissue

Procedure: Cryosurgery
Undergo cryoablation
Other Names:
  • Ablation, Cryo
  • Cryoablation
  • cryosurgical ablation




Primary Outcome Measures :
  1. Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells [ Time Frame: After cryoablation of mesothelioma up to 1 year ]
    Will be tested by cryoablating a small region of tumor at the time of pleural biopsy.

  2. Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue [ Time Frame: Up to 1 year ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429204


Locations
Layout table for location information
United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Neema Jamshidi UCLA / Jonsson Comprehensive Cancer Center
Layout table for additonal information
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04429204    
Other Study ID Numbers: 19-001175
NCI-2020-00640 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-001175 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial