Testing Atezolizumab in Children and Teens with Clear Cell Sarcoma or Advanced Chondrosarcoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04458922
This study is exploring how well the drug atezolizumab works in treating children and teens with newly diagnosed or advanced clear cell sarcoma or chondrosarcoma that cannot be removed by surgery or has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
This phase II clinical trial is testing the effectiveness of atezolizumab, an immunotherapy drug, in helping the immune system attack cancer cells in children and teens with clear cell sarcoma or chondrosarcoma. The study focuses on cases where the cancer is newly diagnosed, cannot be surgically removed, or has spread to other areas.
Description
The main goal of this study is to see how well atezolizumab works in shrinking tumors in children and teens with clear cell sarcoma or chondrosarcoma. Researchers will measure the response of the tumors to the treatment using specific criteria. They will also look at how long the response lasts and how the treatment affects the patients' symptoms and survival without the cancer getting worse.
Participants will receive atezolizumab through an IV every 21 days, as long as the cancer does not progress or cause severe side effects. During the study, patients will have CT scans and provide blood samples to monitor their response to the treatment.
After finishing the treatment, patients will be followed up for up to 90 days to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a specific type of clear cell sarcoma or chondrosarcoma that cannot be cured by surgery.
- Must have at least one tumor that can be measured by scans or exams.
- Must be 2 years or older at the National Cancer Institute or 12 years or older at other sites.
- Must be in good overall health with a performance status score of 2 or less.
- Must have a life expectancy of more than 3 months.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must not be pregnant and agree to use effective birth control during and after the study.
- Must be willing to provide biopsy samples for research if 18 years or older.
- Must be able to understand and sign a consent form or have a parent/guardian do so.
Exclusion Criteria
- Must not have received any prior therapy within a specified time before joining the study.
- Must not have had prior treatment with certain immune therapies like anti-PD-1 or anti-PD-L1 antibodies.
- Must not have any uncontrolled illnesses or infections.
- Must not have a history of severe allergic reactions to similar drugs.
- Must not be pregnant or breastfeeding.
- Must not have active tuberculosis or severe infections recently.
- Must not have had major surgery recently or plan to have it during the study.
- Must not have received a live vaccine recently or plan to receive one during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UF Health Cancer Institute - Gainesville | 32610 | Gainesville | Florida |
| Emory University Hospital Midtown | 30308 | Atlanta | Georgia |
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| National Cancer Institute Developmental Therapeutics Clinic | 20892 | Bethesda | Maryland |
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
| NCI - Center for Cancer Research | 20892 | Bethesda | Maryland |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Siteman Cancer Center-South County | 63129 | St Louis | Missouri |
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