PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma (NCT03299309)
🩺 Plain-English Summary (8th-Grade Level)
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 can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (11 items).
Location: Duke University Medical Center — Durham, North Carolina
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).
- Active infection requiring treatment or an unexplained febrile (\> 101.5 degrees F) illness.
- Known immunosuppressive disease or human immunodeficiency virus infection.
- Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
- Patients receiving concomitant immunosuppressive agents for medical condition.
- Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent Grade III or IV glioma.
- Patients receiving any other investigational drug therapy.
- Patients on corticosteroids \> 0.1 mg/Kg/day (i.e. \> the maximum dose of 4 mg/day).
- Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
- Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Duke University Medical Center — Durham, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.