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Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Primary Purpose

Mesothelioma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cryotherapy

Control

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subject provides informed consent
Subject is >18 years of age
Subject is deemed competent for making medical decisions
Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma
A negative pregnancy test is required in women of child-bearing potential, as standard of care.
Subject is mentally capable of understanding study procedures.

Exclusion Criteria

Study subject has any disease or condition that interferes with safe completion of the study including:

Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5
Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published
Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements.
Concurrent participation in another study involving investigational drugs or investigational medical devices
Absence of or limited access to the pleural space during medical pleuroscopy.
Inability to read and understand the necessary study documents.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cryotherapy

Control

Arm Description

Cryospray and biopsies

Biopsies

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events

Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.

Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples

Secondary Outcome Measures

Full Information

NCT ID

NCT02464904

First Posted

May 14, 2015

Last Updated

January 26, 2022

Sponsor

Mayo Clinic

Collaborators

CSA Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02464904

Brief Title

Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Official Title

Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Difficulty enrolling patients due to enrollment criteria.

Study Start Date

July 2015 (undefined)

Primary Completion Date

February 26, 2021 (Actual)

Study Completion Date

February 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

CSA Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory changes, resulting in the induction of anti-tumor immunity?

Detailed Description

Patients that have been diagnosed, or are suspected of having malignant pleural mesothelioma, a cancer of the pleura, surgery may be considered as an attempt to treat the cancer. As part of the testing needed before surgery, a pleuroscopy or video camera examination of the pleura is necessary to establish the diagnosis and/or to evaluate the extent of the cancer. This study evaluates the effects of cryotherapy (freezing spray) on the ability of a patient's immune system to attack the cancer, as has been reported in other types of cancers. The purpose of this research is to gather information on the safety and effectiveness of cryotherapy in patients with malignant pleural mesothelioma. If successful, this study could provide support for future studies evaluating this new treatment for mesothelioma.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryotherapy

Arm Type

Experimental

Arm Description

Cryospray and biopsies

Arm Title

Control

Arm Type

Other

Arm Description

Biopsies

Intervention Type

Procedure

Intervention Name(s)

Cryotherapy

Intervention Description

Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). The procedure will involve 2 to 3 applications of cryospray on the location of the disease. After establishing cryofrost over a minimum of a 2 x 2 cm area, cryospray will continue for 15 to 20 seconds, allow a thaw period of 60 seconds followed by one to two repeats in the same location before proceeding onto the next location. We will treat a minimum of 6 x 6 cm area in aggregate. The freezing procedure will be video-recorded and freezing locations and time will be recorded. Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.

Time Frame

1 month

Title

Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Subject provides informed consent Subject is >18 years of age Subject is deemed competent for making medical decisions Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma A negative pregnancy test is required in women of child-bearing potential, as standard of care. Subject is mentally capable of understanding study procedures. Exclusion Criteria Study subject has any disease or condition that interferes with safe completion of the study including: Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5 Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians. Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements. Concurrent participation in another study involving investigational drugs or investigational medical devices Absence of or limited access to the pleural space during medical pleuroscopy. Inability to read and understand the necessary study documents.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shanda H Blackmon, MD, MPH

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

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