Cryoablation + Immunotherapy for Cancer

Overseen By Alda L Tam

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

15 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 11 12}

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

I am post-menopausal or not pregnant if pre-menopausal.

I previously responded to immunotherapy but my cancer has since worsened.

I have at least two cancer lesions untreated by targeted therapies, measurable by CT or MRI.

Exclusion Criteria

I have had side effects from previous immune therapy that haven't fully improved.

I have not received a live vaccine in the last 30 days.

I am not pregnant or nursing and if capable of becoming pregnant, I am using effective birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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.

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after cryoablation, with follow-up lasting up to 12 months post-treatment.

12 months

Long-term follow-up

Participants are periodically monitored for progression and survival outcomes up to 2 years.

Up to 2 years

Treatment Details

Interventions

• Cryosurgery
• Immunotherapeutic Agent

Trial Overview The study investigates the effectiveness of cryoablation—a technique where a probe freezes tissue around tumors—in addition to ongoing immunotherapy in treating metastatic cancer. The goal is to see if freezing the tumor cells can enhance the effects of standard immunotherapy treatments.

Participant Groups

Group I: Treatment (cryoablation) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Cryoablation is gaining popularity as a primary treatment for localized cancers and as a salvage therapy for metastatic cancers, showing promise in inducing a systemic antitumor immune response.

To enhance the immune response triggered by cryoablation, combining it with other immunomodulatory agents could create a more effective cryoimmunotherapeutic strategy, potentially improving outcomes for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer immunotherapy using tumor cryoablation. Sidana, A.[2014]

Immunotherapy is becoming an effective treatment for pediatric cancers, offering a different mechanism of action compared to traditional chemotherapy, which leads to unique adverse events (AEs).

A systematic review of 17 articles identified common AEs associated with five key immunotherapy agents, emphasizing the need for nurses to understand these specific AEs to effectively monitor and manage pediatric patients undergoing immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology Group Withycombe, JS., Carlson, A., Coleman, C., et al.[2022]

Cryoablation is a safe and well-tolerated outpatient procedure that can treat small breast cancers and metastatic sites, especially in patients who cannot undergo surgery.

Recent studies indicate that cryoablation may enhance the immune system's ability to recognize and attack cancer cells by increasing the expression of tumor neoantigens, potentially improving the effectiveness of immunotherapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation and Immunotherapy for Breast Cancer: Overview and Rationale for Combined Therapy. Regen-Tuero, HC., Ward, RC., Sikov, WM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Cancer immunotherapy using tumor cryoablation. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Improved synergetic therapy efficiency of cryoablation and nanoparticles for MCF-7 breast cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Cryoablation and immunotherapy of cancer. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cryoablation and Immunotherapy: An Enthralling Synergy for Cancer Treatment. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The future of cryoablation: An abscopal effect. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse event profile for immunotherapy agents compared with chemotherapy in solid organ tumors: a systematic review and meta-analysis of randomized clinical trials. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology Group [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Programmed Death-1 Inhibition in Cancer With a Focus on Non-Small Cell Lung Cancer: Rationale, Nursing Implications, and Patient Management Strategies. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Immune-Related Adverse Events in Cancer Patients Treated With Immune Checkpoint Inhibitors. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Cryoablation and Immunotherapy for Breast Cancer: Overview and Rationale for Combined Therapy. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Immunological Aspects of Cryoablation of Non-Small Cell Lung Cancer: A Comprehensive Review. [2019]