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Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

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?

Tracking Information
First Received DateMay 14, 2015
Last Changed DateDecember 20, 2016
Start DateJuly 2015
Anticipated Primary Completion DateJune 2017
Primary Outcome Measures

Number of Participants with Adverse Events [Time Frame: 1 month]

Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples [Time Frame: 14 days]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Device: Cryotherapy
  • Other: Control
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment15
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Karlyn Pierson, RN, MAN
Email: pierson.karlyn@mayo.edu
Phone: 507-538-1960
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.

Administrative Information
NCTIDNCT02464904
Responsible Party,
SponsorMayo Clinic
Verification DateDecember 2016
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