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Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT02464904
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
CSA Medical, Inc.
Information provided by (Responsible Party):
Shanda Blackmon, M.D., M.P.H., Mayo Clinic

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 Device: 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Cryotherapy
Cryospray and biopsies
Device: 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




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 ]


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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.

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): NCT02464904


Contacts
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Contact: Karlyn Pierson, RN, MAN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg, MBA 507-266-4819 lechtenberg.bettie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn Pierson, RN, MAN    507-538-1960    pierson.karlyn@mayo.edu   
Contact: Bettie Lechtenberg, MBA    507-266-4819    lechtenberg.bettie@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
CSA Medical, Inc.
Investigators
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Principal Investigator: Shanda H Blackmon, MD, MPH Mayo Clinic

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Responsible Party: Shanda Blackmon, M.D., M.P.H., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02464904     History of Changes
Other Study ID Numbers: 14-008715
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial