All studies
Active not recruitingPHASE2INTERVENTIONAL

Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma

This research study is looking at a medicine called Atezolizumab for children and young people aged 2 to 17 who have certain rare cancers, specifically clear cell sarcoma or advanced chondrosarcoma. These are cancers that either can't be removed by surgery or have spread to other parts of the body. Atezolizumab is a type of immunotherapy. This means it works by helping your body's own defence system (your immune system) to better recognise and attack cancer cells. The study wants to find out how effective this medicine is and if it can stop the cancer from growing or spreading. Researchers will be carefully checking how patients respond to the treatment.

At a glance

Results

Results from this study

Posted October 2023

Results have been published for this study.

Primary outcome
Objective Response Rates (ORR)
ORR was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, which involves the following response definitions. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Full results on the registry

What is this study about?

This study is trying to find out if a new medicine called Atezolizumab can help children and young people (aged 2 to 17) who have certain types of cancer: clear cell sarcoma or advanced chondrosarcoma. These are quite rare cancers, and for some people, they can be difficult to treat, especially if they have spread to other parts of the body or cannot be removed through surgery.

Atezolizumab is an 'immunotherapy' drug. Think of it like a boost for your body's natural security system, called the immune system. Normally, your immune system is good at fighting off germs, but sometimes cancer cells can hide from it. Atezolizumab aims to help your immune system to better recognise and attack these cancer cells, potentially stopping them from growing and spreading. This study is in 'Phase 2', which means it's testing whether the medicine works well and is safe in a larger group of people, after earlier stages showed promise.

The main goal of the study is to see how many patients respond to the treatment, meaning their cancer shrinks or stops growing. They will also look at how long this response lasts and how long patients live without their cancer getting worse. Researchers will also be collecting extra information, such as blood and tissue samples, to understand why the medicine works for some people and not others, and how it affects the cancer at a microscopic level.

Key takeaways

  • Tests a new immunotherapy for clear cell sarcoma or advanced chondrosarcoma.
  • Aimed at children and young people aged 2 to 17.
  • Treatment is given every three weeks via an intravenous drip.
  • Regular scans, biopsies, and blood tests will monitor progress.
  • The goal is for the immune system to better fight the cancer.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, patients generally need to be between 2 and 17 years old and have a confirmed diagnosis of clear cell sarcoma or a specific type of advanced chondrosarcoma. The cancer must be one that cannot be cured by surgery, or has spread to other parts of the body.

Patients will need to be well enough to take part, as assessed by the medical team. This means they should have generally good health otherwise, with their important organs like the liver and kidneys working properly. They must also have measurable cancer that doctors can keep an eye on to see if the treatment is working.

There are also some specific medical requirements, such as certain blood test results, which the study doctors will explain in detail. Patients cannot have other serious health problems that might make the treatment unsafe. The study team will review all medical information to see if someone is a good fit for the trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 2 and 17 years old?
  2. Do you have clear cell sarcoma or a specific type of advanced chondrosarcoma?
  3. Has your doctor said your cancer cannot be cured by surgery or has spread?
  4. Are you generally well enough to participate, as assessed by your doctor?
  5. Are you willing to have regular scans, blood tests, and biopsies?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medicine, Atezolizumab, through a drip into your vein (like a blood transfusion). This treatment will be given on day 1 of a 21-day cycle, meaning you would have it every three weeks. Each treatment session will last between 30 to 60 minutes.

Throughout the study, you will have regular check-ups, which include appointments and several tests. These tests typically involve CT scans (a special X-ray that takes detailed pictures inside your body) to monitor the cancer. You will also have biopsies (small tissue samples taken from the tumour) and blood samples collected to help researchers understand more about your cancer and how the medicine is working. You will continue with this treatment for as long as it is helping you and you are not experiencing severe side effects. After the treatment ends, you will have follow-up appointments for up to 90 days to see how you are doing.

Potential risks and benefits

Participating in this study might offer a potential benefit if Atezolizumab helps to shrink your cancer or slow its growth, as this medicine is still being tested and is not yet a standard treatment for these cancers. However, there's no guarantee the treatment will work for everyone, or that it will be better than existing treatments. Like all medicines, Atezolizumab can have side effects, which the study team will explain fully. These can range from mild to more serious, and the medical team will monitor you closely for any unwanted effects. You are always in control and can choose to stop participating in the study at any time, for any reason, without affecting your future medical care.

Locations (15)

  • USC / Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States
  • UF Health Cancer Institute - Gainesville
    Verified postcode
    Gainesville, United States
  • Emory University Hospital Midtown
    Verified postcode
    Atlanta, United States
  • Emory University Hospital/Winship Cancer Institute
    Verified postcode
    Atlanta, United States
  • National Cancer Institute Developmental Therapeutics Clinic
    Verified postcode
    Bethesda, United States
  • National Institutes of Health Clinical Center
    Verified postcode
    Bethesda, United States
  • NCI - Center for Cancer Research
    Verified postcode
    Bethesda, United States
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States
  • Siteman Cancer Center-South County
    Verified postcode
    St Louis, United States
  • Ohio State University Comprehensive Cancer Center
    Verified postcode
    Columbus, United States
  • University of Pittsburgh Cancer Institute (UPCI)
    Verified postcode
    Pittsburgh, United States

Common questions

What is Atezolizumab?

Atezolizumab is a type of immunotherapy that helps your body's immune system fight cancer cells.

What types of cancer is this study for?

This study is for children and young people with clear cell sarcoma or advanced chondrosarcoma that cannot be operated on or has spread.

How will I receive the treatment?

The medicine will be given through a drip into your vein about every three weeks.

Will I have other tests during the study?

Yes, you will have regular CT scans, biopsies (tissue samples), and blood tests to monitor your health and the cancer.

Can I stop being part of the study?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.