DERIVe (Glioblastoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to understand whether the study vaccine, called pp65 CMV dendritic cells, can trigger your immune (protection) system to fight off the tumor cells in your brain.

What is the Condition Being Studied?

Glioblastoma

Who Can Participate in the Study?

Adults who:
-Have been newly diagnosed with glioblastoma and had surgery to remove most of the tumor tissue
-Do not have severe reactions to imaging contrast dyes
-Do not have a different cancer requiring active treatment
-Are not taking any types of medicines that affect your immune system.
-Have not had any other medications for your tumor other than steroids prior to starting the study outside of chemo-radiation

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 returns the blood back into a vein in the other arm.
-We will take those white blood cells and create Dendritic Cells (DCs) which will be used to make vaccines
-Be randomly assigned (like drawing numbers from a hat) to 1 of 3 groups:
--Group 1 will get unpulsed dendritic cell pre-conditioning prior to DC vaccine #4,
--Group 2 will get tetanus booster prior to DC vaccine #4,
--Group 3 will get tetanus booster prior to DC vaccine #4 and varlilumab (an anti-tumor drug). Varlilumab will be infused (into the vein) 7 days prior to receiving DC vaccines

Both groups will:
-Be asked to come to Duke every 2 weeks for the first 3 vaccines and once a month after the 3rd vaccine (for up to 21 months).
-Have physical exams and blood samples taken
-Have MRI scans as needed

Study Details

Full Title
DERIVe: DC Migration Study to Evaluate TReg Depletion In GBM Patients with and without Varlilumab
Principal Investigator
Neuro-oncologist
Protocol Number
IRB: PRO00082570
NCT: NCT03688178
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698