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Active, not recruitingNCT03299309PRiMEUpdated Jun 18, 2026

PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

A Phase 1 interventional study of PEP-CMV in Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood and Malignant Glioma, sponsored by Daniel Landi. Active, not recruiting at 1 site in United States. Open to participants aged 3 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Daniel Landi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
3 Years to 35 Years
Sex
All
01

Study summary

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.

Read the detailed description

Once a patient has enrolled onto this study, prior therapy will be terminated and patients will receive temozolomide 200 mg/m2/day x 5 days. If they are receiving bevacizumab at the time of enrollment, they will continue bevacizumab 10 mg/Kg every 14 days.

Patients who are ≥ 18 years of age will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Tetanus (Td) pre-conditioning vaccine delivered intradermally (i.d.) in the right groin at the site of the vaccine injection 6-24 hours prior to the first vaccine on day 21. The PEP-CMV vaccine will be administered as follows: PEP-CMV Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.

The first 3 PEP-CMV vaccines will occur every 2 weeks, then PEP-CMV vaccines will continue monthly (+/- 2 weeks) for no more than 10 years. Blood will be obtained for immune system monitoring.

In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.

02

Conditions studied

  • Recurrent Medulloblastoma
  • Recurrent Brain Tumor, Childhood
  • Malignant Glioma

Keywords

  • Glioma
  • Medulloblastoma
  • PRiME
  • Pro00079843
  • Thompson
  • Pediatric
  • Landi
03

Who can participate

Ages eligible
3 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    PEP-CMV

    Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV)

    Drug: PEP-CMV

Interventions

  • DrugPEP-CMV

    Patients receive temozolomide (TMZ) 200 mg/m2/day x 5 days. On day 20, patients will receive a Tetanus-diphtheria pre-conditioning vaccination with Td (tetanus, diphtheria toxoid, adsorbed). Immunotherapy begins the following day, on day 21, with injection of the PEP-CMV vaccine as follows: PEP-CMV Component A mixed with Montanide ISA-51 intradermally administered half in the RIGHT groin and half in the LEFT groin.

    Also known as: PEP-CMV vaccine

05

What researchers measure

Primary outcomes

  1. Proportion of patients with unacceptable toxicity

    Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma

    Time frame: 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient

Secondary outcomes

  1. Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN-γ)

    Quantitate the immune response to the components of the PEP-CMV vaccine by ELISPOT

    Time frame: 24 months

  2. Mean or median change from baseline at each follow-up assessment in ELISA (gB-KLH)

    Quantitate the immune response to the components of the PEP-CMV vaccine by ELISA

    Time frame: 24 months

06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03299309
Lead sponsor
Daniel Landi
Collaborators
Pediatric Brain Tumor Foundation, Annias Immunotherapeutics, Inc.
Responsible party
Daniel Landi (Assistant Professor of Pediatrics and Neurosurgery, Duke University) — Sponsor-investigator
First posted
Oct 3, 2017
Start date
Jun 29, 2018
Primary completion
Apr 27, 2023
Completion
May 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

Daniel Landi, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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