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Atezolizumab + Cabozantinib for Osteosarcoma
Study Summary
This trial is studying giving atezolizumab and cabozantinib to see how well it works in treating adolescents and young adults with osteosarcoma that has come back or has spread to other places in the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 45 Patients • NCT02101736Trial Design
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- I am mostly active and can care for myself despite my illness.My calcium levels are normal and not causing symptoms.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.My platelet count is at least 100,000 without needing a transfusion.I have not had significant bleeding or coughed up more than half a teaspoon of blood in the last 3 months.My diagnosis of bone cancer is confirmed by tissue examination.My high blood pressure is not controlled despite treatment.I am not pregnant and cannot become pregnant due to sterilization or being postmenopausal.My side effects from previous treatments are mild or back to normal.My blood clotting tests are within normal limits and I'm not on blood thinners.My cancer did not respond or has returned after treatment with specific chemotherapy drugs.I agree to either not have sex or use a condom, and not donate sperm.I can provide a tumor sample in a paraffin block or at least 15 slides for the study.My brain metastases are stable, treated, and I'm not on steroids.I haven't had major surgery in the last 4 weeks or minor surgery in the last 10 days.I have lung lesions or disease in my airways.I have had leptomeningeal disease.I haven't taken any kinase inhibitor medication in the last 2 weeks.I frequently need procedures to remove excess fluid from my body.I cannot swallow pills.I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.My liver function is significantly impaired.I am 12 years old or older.I have had treatments with specific immune therapy drugs, possibly combined with a drug targeting blood vessel growth.I am currently taking certain blood thinners.I have pain from my cancer that isn't relieved by treatment.My cancer can be measured by scans and has grown after radiation.My cancer has spread and cannot be removed by surgery.I haven't had major heart issues or strokes in the last 3 months.I haven't had a stroke, heart attack, or blood clot in the last 6 months.My cancer is growing into or around major blood vessels.My body surface area is at least 1 square meter.I can provide a recent tumor sample for research.My kidney function, measured by creatinine clearance, is sufficient.My alkaline phosphatase levels are within the normal range, even with bone metastases.My white blood cell count is healthy without needing medication.I have or had an autoimmune disease or immune deficiency.I have been treated with cabozantinib before.I haven't had any cancer treatment in the last 4 weeks.I have symptoms of underactive thyroid that aren't treated.I have a GI disorder that could lead to holes or abnormal connections in my digestive tract.My heart's electrical activity (QTcF) is not over 500 ms.My liver tests, AST and ALT, are within normal limits.
- Group 1: Treatment (atezolizumab, cabozantinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this research a precedent-setting endeavor?
"Research on cabozantinib has been ongoing since 2008. To date, Hoffmann-La Roche alone has conducted 135 trials of the medication across 75 countries and 1911 cities. Currently, there are 447 active studies that involve cabozantinib in some capacity."
How can we be sure that Cabozantinib is secure to use?
"Cabozantinib's safety is rated at 2, as it has only undergone a Phase 2 trial with limited evidence backing its efficacy."
Are there vacancies available for anyone interested in participating in this research?
"The current study is not currently recruiting. As of August 31st, 2022, it has been posted for 8 months since December 1st, 2022. Other studies pertaining to refractory osteosarcoma and Cabozantinib are actively accepting patients with 1114 and 447 trials respectively."
To what uses is Cabozantinib commonly allocated?
"Cabozantinib is an effective treatment for small cell lung cancer (SCLC) that has previously been treated with anti-VEGF and malignant neoplasms."
To what extent is this research being conducted with participants?
"Unfortunately, the recruitment period for this trial has now come to an end. It was first posted on December 1st 2022 and last amended August 31st 2022. However, prospective participants may be interested to know that there are still 1114 trials searching for those with refractory osteosarcoma and 447 trials actively recruiting patients taking Cabozantinib."
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