Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

• ClinicalTrials.gov Identifier: NCT02464904
• Recruitment Status: Terminated
• First Posted: June 8, 2015
• Last Update Posted: February 9, 2022
• Sponsor: Mayo Clinic
• Collaborator: CSA Medical, Inc.
• Information provided by (Responsible Party): Shanda Blackmon, M.D., M.P.H., Mayo Clinic

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?

Condition or disease	Intervention/treatment	Phase
Mesothelioma	Procedure: Cryotherapy; Other: Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy
• Study Start Date: July 2015
• Actual Primary Completion Date: February 26, 2021
• Actual Study Completion Date: February 26, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cryotherapy; Cryospray and biopsies	Procedure: Cryotherapy; 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.
Control; Biopsies	Other: Control; 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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants with Adverse Events [ Time Frame: 1 month ]
   Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.
2. Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples [ Time Frame: 14 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

CSA Medical, Inc.

Investigators

• Principal Investigator: Shanda H Blackmon, MD, MPH; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Shanda Blackmon, M.D., M.P.H., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02464904
• Other Study ID Numbers: 14-008715
• First Posted: June 8, 2015
• Last Update Posted: February 9, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mesothelioma; Mesothelioma, Malignant; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases