This study is being done to test new treatments for people with newly diagnosed glioblastoma (GBM), a type of brain cancer. The goal is to see if any of these new treatments help people live longer compared to the usual treatments. This study will compare the usual medicine (Temozolomide) used to treat newly diagnosed GBM to new drugs such as VT102, ADI-PEG20, Troriluzole, or AZD1390.
The goals of this study are to find treatments that work for GBM and to match the best treatments with different types of people. If you choose to join the study, your first visit will be to see if you qualify for the treatment part. Your study doctor will ask you questions about your health, your medical history, and any medicines you take. You will have a physical exam and a neurological exam. We will check your blood pressure, temperature, heart rate, height, and weight. You will also get an MRI scan of your brain and an electrocardiogram, which checks your heart. You will have a blood test, a urine test, and a sample will be taken from your tumor. This part of the study will last 28 days. If you qualify for the treatment phase, you will be randomly placed into a group that gets either the usual treatment or the usual treatment plus one of the new study drugs available at this time, such as, VT1021, ADI-PEG20, Troriluzole, or AZD1390. The new study drugs available on the study will change over time. This process is like flipping a coin. You will not be able to choose which treatment you get. Once you are assigned to a treatment group, your study doctor will tell you which study drug you will get and explain the details of your treatment. If you are placed in the control group, you will get the standard treatment for GBM. This means you will get Temozolomide and radiation treatment. No matter which treatment you get, you will be asked to complete similar testing and assessments like the ones you completed during your screening period. This part of the study will require several in-person visits, and different study drugs require different on-site requirements so you can get the treatment. Some of them require you to come to in-person visits once or twice each week during your treatment. The total time you spend in the study will depend on how well you handle the treatment. The study will pay for any tests or procedures that are only needed for the study. You and your insurance will need to pay for all tests and procedures that are routine medical care. You will not be paid for your participation in the study. You may be able to get money back for travel costs.
You may be able to join this study if you are 18 years or older and have been diagnosed with glioblastoma.
Protocol Number: 19-0744
More information available at ClinicalTrials.gov: NCT03970447
Principal Investigator