PEP-CMV Vaccine for Recurrent Brain Tumor
(PRiME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.
Who Is on the Research Team?
Daniel Landi, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for patients aged 3-35 with recurrent medulloblastoma or malignant glioma who've had prior treatment. They must have stable neurological deficits, if any, and meet specific blood count and organ function criteria. Pregnant individuals, those with active infections or other serious illnesses, or on high-dose steroids are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive temozolomide and PEP-CMV vaccine. Temozolomide is administered for 5 days, and the PEP-CMV vaccine is given every 2 weeks for the first 3 doses, then monthly.
Follow-up
Participants are monitored for safety and immune response effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PEP-CMV
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eric Thompson, M.D.
Lead Sponsor
Gary Archer Ph.D.
Lead Sponsor
Daniel Landi
Lead Sponsor
Pediatric Brain Tumor Foundation
Collaborator
Annias Immunotherapeutics, Inc.
Collaborator