I-ATTAC (Brain Tumor) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to confirm that our vaccine can stimulate your immune system and is safe to receive.

What is the Condition Being Studied?

Grade IV malignant glioma (brain tumor) that is newly diagnosed

Who Can Participate in the Study?

Adults age 18 and older who:
-Have been newly diagnosed with Grade IV malignant glioma
-Have antibodies against cytomegalovirus in your blood
-Do not have severe reactions to imaging contrast dyes (used during an MRI)
-Do not have anything in your body that would prevent you from having an MRI (such as metal in your body)

For more information about who can be in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Have a procedure where your blood is taken out of a vein in one arm, goes through a machine that takes out white blood cells, and then returns the remaining blood into a vein in the other arm.
-We then take your white blood cells and create vaccines in a lab at Duke.
-Have standard radiation treatment and chemotherapy over 6 weeks
-Have one cycle of high-dose chemotherapy
-Have a tetanus shot
-Receive 3 vaccines (one every 2 weeks) followed by up to 7 more vaccines about every month
-Complete regular clinic visits to receive vaccines and have physical examinations, bloodwork, and regular MRIs.
-Be a part of this study for up to 2 years

Study Details

Full Title
I-ATTAC: Improved Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients with Newly-Diagnosed WHO Grade IV Unmethylated Glioma
Principal Investigator
Protocol Number
IRB: PRO00090683
NCT: NCT03927222
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698