MesotheliomaNCT02464904
Intrapleural Cryotherapy for Malignant Pleural Mesothelioma
A study testing Cryotherapy in people with Mesothelioma, run by Mayo Clinic at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 26 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy
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?
Read the 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.
- Conditions
- Mesothelioma
- Being tested
- Cryotherapy, Control
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
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.
ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Cryospray and biopsies Receives: Procedure: Cryotherapy |
| Control | Other | Biopsies Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.
Measured: 1 month
Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Why it stopped: Difficulty enrolling patients due to enrollment criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- CSA Medical, Inc.
- Responsible party
- Principal investigator, Shanda Blackmon, M.D., M.P.H., Mayo Clinic
- Investigators
- Shanda H Blackmon, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464904
- Sponsor's protocol ID
- 14-008715
- Status last verified
- Jan 2022
- First submitted
- 14 May 2015
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy
- ClinicalTrials.gov ID
- NCT02464904
- Acronym / sponsor ID
- 14-008715
- Conditions
- Mesothelioma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients due to enrollment criteria.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- CSA Medical, Inc.
- Study start
- Jul 2015
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Procedure: CryotherapyCryospray and biopsies |
| Control | Other | Other: ControlBiopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapySubjects 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. | Procedure or surgery | Cryotherapy |
| ControlSubjects 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 | Other | Control |
Primary outcome
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.
Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Difficulty enrolling patients due to enrollment criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanda H Blackmon, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Mesothelioma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty enrolling patients due to enrollment criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.