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?
|First Received Date||May 14, 2015|
|Last Changed Date||January 7, 2019|
|Start Date||July 2015|
|Anticipated Primary Completion Date||December 2020|
|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]
|Study Arms / Comparison Groups||2 / 0|
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.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Karlyn Pierson, RN, MAN
- 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.
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.
|Responsible Party||Principal Investigator|
|Verification Date||January 2019|