PEP-CMV Vaccine for Recurrent Brain Tumor
(PRiME Trial)
Trial Summary
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.
Research Team
Daniel Landi, MD
Principal Investigator
Duke University
Eligibility Criteria
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
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
Treatment Details
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