Your session is about to expire
← Back to Search
Immunotherapy
Cryoablation + Immunotherapy for Cancer
N/A
Waitlist Available
Led By Alda L Tam
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have at least two lesions not previously treated with loco-regional therapy (including external beam radiation, embolization (bland or chemo), Y90, prior ablation (i.e. microwave, radiofrequency ablation, cryoablation, irreversible electroporation) that can be accurately measured in at least one dimension (longest diameter to be recorded) as >=10 mm with spiral computed tomography [CT] scan or >= 20 mm with magnetic resonance imaging [MRI])
Creatinine within normal institutional limits OR - creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will study whether adding cryoablation treatment to standard of care immunotherapy can help to kill cancer cells in patients with metastatic cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Cryoablation may cause discomfort at the site of treatment, potential damage to nearby tissues or organs due to freezing temperatures. Immunotherapeutic agents could lead to immune system reactions affecting various organs, fatigue, skin reactions among other side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least two cancer lesions untreated by targeted therapies, measurable by CT or MRI.
Select...
My kidney function is normal or meets the minimum clearance rate.
Select...
I am a woman who is either not pregnant, post-menopausal, or have had surgery to prevent pregnancy.
Select...
I received most of my PD1/PD-L1 therapy as planned in the last 3 months.
Select...
I am mostly active and can care for myself.
Select...
I have metastatic cancer and am on standard immunotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best objective response (complete response or partial response)
Secondary outcome measures
Changes in T-effector cell populations
Disease control rate (CR + PR + stable disease [SD])
Duration of response
+6 moreOther outcome measures
Immune parameters
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cryoablation)Experimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core Biopsy
2013
N/A
~130
Cryosurgery
2015
Completed Phase 4
~540
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,306 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,058 Total Patients Enrolled
Alda L TamPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had side effects from previous immune therapy that haven't fully improved.I am post-menopausal or not pregnant if pre-menopausal.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.I previously responded to immunotherapy but my cancer has since worsened.I am not on hormonal therapy for cancer, but may be for other conditions.I have at least two cancer lesions untreated by targeted therapies, measurable by CT or MRI.I am not on strong immune system suppressing drugs, except for minor exceptions like inhalers or low-dose steroids.I have or had an autoimmune or inflammatory disorder but might still qualify based on specific conditions.I do not have any severe illnesses that could interfere with the study.My kidney function is normal or meets the minimum clearance rate.My lesion has not been treated with any local therapies before.I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.I am a woman who is either not pregnant, post-menopausal, or have had surgery to prevent pregnancy.You have received an organ transplant from someone else in the past.You are expected to live for at least 6 more months.I don't have active brain issues, seizures, or untreated brain metastases.You have a history of a weak immune system that makes it difficult for your body to fight off infections.You have a severe allergy or a known reaction to the dye used for imaging tests that cannot be treated.I received immunotherapy in the last 4 weeks and haven't needed high-dose steroids.I received most of my PD1/PD-L1 therapy as planned in the last 3 months.I can safely continue my current immunotherapy for at least 3 months after cryoablation.I have had treatments for my cancer, including surgery to remove metastases.I am mostly active and can care for myself.I have metastatic cancer and am on standard immunotherapy.I have another cancer that could affect the study treatment's safety or results.I do not have lesions that can be biopsied or measured.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cryoablation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enrolled into this clinical trial?
"Affirmative. Clinicaltrials.gov attests to the fact that this experiment, initially published on December 23rd 2019 is currently in search of volunteers. A total of 25 subjects need to be recruited from a single clinical site."
Answered by AI
Is there still capacity for individuals to join this experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this trial is still open to new participants, with a posted date of December 23rd 2019 and most recent edit on August 1st 2022. 25 individuals are required from one medical facility."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger