10005 A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test any good and bad effects of the study drug called atezolizumab. Atezolizumab works by unblocking your immune system, allowing your immune system cells to recognize and then attack your tumor cells.
Generally healthy adults with advanced aleveolar soft part sarcoma that is not curable by surgery and for which there is no standard treatment may be eligible.
Each adult taking part in this study will receive the same dose that is used for standard of care with the study drug atezolizumab: children will get a lower unapproved dose. You will be able to receive additional doses of the drug for as long as you remain in the study.Treatment will be given in the outpatient setting, so you won’t have to stay overnight in the hospital or clinic. Atezolizumab will be given by vein into your arm. It will take about 1 hour to give the study drug. You may need to stay at the hospital for 2-3 hours after the first time you get the drug so that your doctor can monitor you. The study drug is given in cycles. Each cycle involves one dose of study drug every 21 days (on same day of each cycle) until you experience unacceptable side effects or your tumor grows.You may continue to receive additional doses of atezolizumab for as long as your cancer does not get worse, the side effects are tolerable, and you agree to stay on study, or until the study doctor decides it is in your best interest to come off atezolizumab. The study may be stopped by the sponsor if they determine the drug is not working.In addition, you may be able to continue treatment with atezolizumab if you are experiencing benefits, even if tests suggest that your cancer is getting worse. In this case, your doctor will discuss with you whether you meet the criteria for remaining on treatment, and you will be asked to sign a separate consent form. However, it is not known at this time if continuing treatment once disease has gotten worse is actually beneficial for you.After you stop treatment, you will remain in the study for monitoring, while your doctor continues to watch you for side effects and follow your condition for 30 days from your last treatment date or until you start a new treatment. If you were removed from the study due to intolerable side effects, you will be followed until these resolve.
03/05/2019 05:03 AM