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ATTAC-II for Patients Patients with Newly-Diagnosed Glioblastoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study vaccine is effective against a type of brain cancer called glioblastoma when it is given with stronger doses of normal chemotherapy.
What is the Condition Being Studied?
Brain Cancer (newly diagnosed glioma)

Who Can Participate in the Study?

Adults 18 years old or older who have been newly diagnosed with glioblastoma.

Age Group
Adults

What is Involved?

If you agree to be in this study:
-You will be randomly (like drawing numbers from a hat) assigned to one of three groups.
--Group 1 will receive the short preparation of the pp65 DC vaccine,
--Group 2 will receive the long preparation of the pp65 DC vaccine,
--Group 3 will receive a placebo that will look like and be given in the same way as the pp65 DC vaccine

- You will undergo a leukapheresis procedure in which blood is collected into a machine that removes white blood cells and then returns the remainder of the blood back to you. The white blood cells removed from the blood are used to make a study vaccine.

- After the leukapheresis, you will have standard treatment for your brain cancer (radiation therapy and chemotherapy) before you get the study vaccines. Vaccines are given as a shot in the leg.

Study Details

Full Title
ATTAC-II: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells with Tetanus-Diphtheria Toxoid Vaccine in Patients with Newly-Diagnosed Glioblastoma
Principal Investigator
Protocol Number
IRB: PRO00084478
NCT: NCT02465268
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698