Clinical trial · Interventional
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
NCT03299309CI-TRIAL-00115254PRiMEactive not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Brain Tumor, Childhood | Childhood Brain Neoplasm | ALIAS | 0.85 |
| Recurrent Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP-CMV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEP-CMV
- description
- Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV)
- interventionNames
- Drug: PEP-CMV
Primary outcomes (1)
- measure
- Proportion of patients with unacceptable toxicity
- timeFrame
- 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient
- description
- Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma
Secondary outcomes (2)
- measure
- Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN-γ)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients who are 3 - 35 years old
2. Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
3. Radiology evidence of recurrent medulloblastoma (reMB) or recurrent Grade III and IV glioma. Patients will be considered for a biopsy or resection of the recurrent/progressive tumor at the discretion of the treating neurosurgeon and neuro-oncologist.
4. Brain MRI within one month prior to enrollment.
5. Received prior therapy for their initial diagnosis prior to recurrence/progression or who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation).
6. Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
7. Karnofsky Performance Status (KPS) of ≥ 60% (KPS for \> 10 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for ≤ 10 years of age) assessed within 2 weeks prior to registration. Patients who are unable to walk because of paralysis but who are up in a wheel chair will be considered ambulatory for the purposes of the performance score.
8. Bone Marrow:
* ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)\*.
* Platelets ≥ 100,000/µl (unsupported)\*.
* Hemoglobin \> 8 g/dL (may be supported).
9. Renal:
• Serum creatinine ≤ upper limit of institutional normal.
10. Hepatic:
* Bilirubin ≤ 1.5 times upper limit of normal for age.
* SGPT (ALT) ≤ 3 times institutional upper limit of normal for age.
* SGOT (AST) ≤ 3 times institutional upper limit of normal for age.
11. Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
12. Signed informed consent according to institutional guidelines must be obtained prior to registration.
13. Any prior chemoradiotherapy is allowed.
Exclusion Criteria:
1. Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).
2. Active infection requiring treatment or an unexplained febrile (\> 101.5 degrees F) illness.
3. Known immunosuppressive disease or human immunodeficiency virus infection.
4. Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
5. Patients receiving concomitant immunosuppressive agents for medical condition.
6. Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent Grade III or IV glioma.
7. Patients receiving any other investigational drug therapy.
8. Patients on corticosteroids \> 0.1 mg/Kg/day (i.e. \> the maximum dose of 4 mg/day).
9. Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
10. Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.References
Publications (0)
Data not yet available
No reference posted for this study.