The PRiME Study, for Brain Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the study vaccine (PEP-CMV) and to understand if it helps the immune system fight brain cancer.

What is the Condition Being Studied?

Brain Cancer (World Health Organization [WHO] Grade III or IV glioma or medulloblastoma)

Who Can Participate in the Study?

Children and adults, 3-35 years old with:
-Grade III or IV glioma that has progressed or recurred
-Medulloblastoma that has progressed or recurred

Age Group
Adults, Children

What is Involved?

If you, or your child, choose to join this study, you or your child will:
- Have a blood test for a common virus called cytomegalovirus (CMV)
- Have standard radiation therapy with temozolomide (a chemotherapy) before study procedures
- Have blood drawn
- Get a Tetanus-diphtheria (Td) vaccine shot (given in the leg)
- Get the study vaccine (PEP-CMV) every 2 weeks for the first 3 vaccines and then once a month

Study Details

Full Title
The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/malignant glioma
Principal Investigator
Pediatric Neurosurgeon
Protocol Number
IRB: PRO00079843
NCT: NCT03299309
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698