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The PRiME Study for Medulloblastoma and Glioma (Brain Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study see if the PEP-CMV vaccine can help 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 aged 3 to 17 years old with:
- WHO Grade III or IV glioma that has progressed or recurred.
- Medulloblastoma that has progressed or recurred

and

Adults aged 18 to 35 years old with:
- Medulloblastoma that has progressed or recurred

Age Group
Children

What is Involved?

If you or your child choose to join this study, you or your child will:
- Have your blood tested for antibodies (substances produced by the body to fight infections) to a common virus called cytomegalovirus (CMV)
- Have standard radiation therapy with temozolomide chemotherapy before beginning study procedures
- Have blood drawn that is routine and blood drawn for research that will look at your immune system
- Get a Tetanus-diphtheria (Td) immunization shot before beginning study vaccines (given as a shot in the leg)
- Get PEP-CMV study vaccines every 2 weeks for the 1st 3 vaccines and then monthly thereafter

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
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698