Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Not Applicable

Terminated

• Conditions: Mesothelioma
• Interventions: Procedure: Cryotherapy; Other: Control

• Registration Number: NCT02464904
• Lead Sponsor: 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?

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 Timeline

• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Study Start: 2015-07
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Cryospray and biopsies
Control	Control	Biopsies

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	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	14 days

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States