Cryoablation for the Treatment of Metastatic Cancer

Status Active, not recruiting

Clinical Trial Summary

This interventional trial studies the effectiveness of adding cryoablation treatment in patients who are receiving standard of care immunotherapy to treat cancer that is has spread to other parts of the body (metastatic). Cryoablation uses a probe that freezes the tissue around the tumor to try to kill the cancer cells. Using cryoablation to treat cancerous lesions may help to kill the cancer cells.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the effect of cryoablation on adaptive resistance to immunotherapy in metastatic cancer patients. SECONDARY OBJECTIVES: I. To assess additional efficacy response to treatment. II. To assess the safety and tolerability of cryoablation in this population. III. To compare the radiologic response of ablated and non-ablated lesions using Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) and RECIST 1.1. IV. To assess the immune effect of cryoablation on the non-ablated lesion using pre- and post-treatment biopsies. EXPLORATORY OBJECTIVE: I. To evaluate the immune microenvironment and systemic changes as a result of cryoablation with the goal of biomarker discovery. OUTLINE: Beginning 1 week prior to the next scheduled standard of care immunotherapy infusion, patients undergo core biopsy of the lesion to be ablated and a non-ablated lesion and also undergo cryoablation. Patients undergo a mandatory second core biopsy of the non-ablated lesion at 4 weeks after cryoablation. After completion of study, patients are followed up for 12 months after cryoablation and then periodically thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04150939
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 23, 2019
Completion date	August 31, 2025

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