Cryoablation + Immunotherapy for Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must continue your current immunotherapy dose regimen for at least 3 months after cryoablation. If you are on immunosuppressive medication, you may need to stop, unless it's a low-dose steroid or for specific conditions like allergies.
What data supports the effectiveness of the treatment Cryoablation + Immunotherapy for Cancer?
Research shows that cryoablation (a technique that freezes cancer cells) can trigger the body's immune system to attack cancer cells more effectively when combined with immunotherapy (treatments that help the immune system fight cancer). Studies have found that this combination can lead to a strong and efficient attack on cancer cells, with some patients showing no new tumor development after treatment.12345
Is the combination of cryoablation and immunotherapy generally safe for humans?
Immunotherapy, which is often used in cancer treatment, can cause a range of side effects related to the immune system, such as skin issues, digestive problems, and hormone imbalances. These side effects are usually manageable with medication or treatment adjustments. While specific safety data for the combination of cryoablation and immunotherapy is not detailed, immunotherapy alone has a known safety profile.678910
How does the Cryoablation + Immunotherapy treatment for cancer differ from other treatments?
This treatment is unique because it combines cryoablation, which freezes and destroys cancer cells, with immunotherapy, which boosts the body's immune system to fight cancer. The freezing process leaves tumor antigens (substances that trigger an immune response) in place, potentially turning the tumor into a sort of 'vaccine' that helps the immune system recognize and attack cancer cells more effectively.1231112
Research Team
Alda L. Tam
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with metastatic cancer who are on standard immunotherapy and have shown some response followed by progression. They must be able to continue their current treatment post-cryoablation, have a life expectancy over 6 months, good performance status, normal organ function tests, and at least two untreated lesions measurable by CT or MRI. Pregnant women or those with uncontrolled illnesses, certain autoimmune diseases without PI approval, prior severe immune-related drug toxicity not recovered to baseline or grade 1 (except alopecia), active infections like TB or hepatitis B/C, known allergies to contrast media agents cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo core biopsy of the lesion to be ablated and a non-ablated lesion, followed by cryoablation. A second core biopsy of the non-ablated lesion is performed 4 weeks after cryoablation.
Follow-up
Participants are monitored for safety and effectiveness after cryoablation, with follow-up lasting up to 12 months post-treatment.
Long-term follow-up
Participants are periodically monitored for progression and survival outcomes up to 2 years.
Treatment Details
Interventions
- Cryosurgery
- Immunotherapeutic Agent
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator