D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients - Clinical Trial
What is the Purpose of this Study?
To join this study, you will go to Duke hospital for surgery. During surgery, doctors will place a small tube called a catheter to give you the study medicine and take a tiny piece of tissue for research. After surgery, you will stay in the hospital while the first medicine, called D2C7-IT, goes in for about three days. Then you will get another medicine called 2141-V11, which takes about seven hours. After the medicines are done, the tube will be removed, and you will be watched for six hours.
About two weeks later, you will come back to start getting shots of 2141-V11 under your skin. You may keep getting these shots for up to a year, and even longer if you want. When you stop the shots, your doctor will decide what follow-up you need.
This study is about a type of brain cancer called glioblastoma. The tumors in this study have a special feature called MGMT promoter unmethylated. Scientists want to learn more about this kind of tumor and how to treat it.
Who Can Participate in the Study?
To join this study, you must be at least 18 years old and have a certain type of brain cancer called glioblastoma. It must be in the top part of the brain and have special features like MGMT unmethylated and IDH wildtype. You need to have finished standard treatment with radiation and medicine called TMZ and still have a small tumor left that can be treated with a catheter. You also need to be healthy enough to take part, with a score called KPS over 70.
You cannot join if you are pregnant or breastfeeding, have very serious health problems, infections, or certain diseases like HIV or hepatitis. You also cannot join if you have had other treatments for this cancer (except surgery and standard care) or if you will not stop using a device called Optune before the study starts.
What is Involved?
The purpose of this study is to find out if giving two medicines, called D2C7-IT and 2141-V11, near the neck lymph nodes is safe and works well for adults who have a brain cancer called glioblastoma. This type of glioblastoma has something special called MGMT promoter unmethylated. MGMT is a substance in the body that helps break down chemicals and is found in brain tumors.
Study Details
