The PRiME Study (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 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