Clinical trial NCT02464904: 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
Overall status: TERMINATED
Phase: NA
Conditions: Mesothelioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: CSA Medical, Inc.
First posted: 2015-06-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 1 month
measure: Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shanda H Blackmon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: