Recurrent MedulloblastomaPhase 1PRiMENCT03299309
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
A Phase 1 study testing PEP-CMV in people with Recurrent Medulloblastoma and Recurrent Brain Tumor, Childhood, run by Daniel Landi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 35 years
- Conditions the study is for
- Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood, Malignant Glioma
- What is being tested?
- PEP-CMV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who are 3 - 35 years old
- Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
- 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.
- Brain MRI within one month prior to enrollment.
- 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).
- Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
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- 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.
- Bone Marrow:
- ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)*.
- Platelets ≥ 100,000/µl (unsupported)*.
- Hemoglobin > 8 g/dL (may be supported).
- Renal:
- Serum creatinine ≤ upper limit of institutional normal.
- 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.
- 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.
- Signed informed consent according to institutional guidelines must be obtained prior to registration.
- Any prior chemoradiotherapy is allowed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
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.
- Being tested
- PEP-CMV
- Keywords
- Glioma, Medulloblastoma, PRiME, Pro00079843, Thompson, Pediatric, Landi
- Medical subject headings
- Medulloblastoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-CMVDrug
Also called PEP-CMV vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| PEP-CMV | Experimental | Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV) Receives: Drug: PEP-CMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with unacceptable toxicity
Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma
Measured: 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient
Secondary outcomes (2)
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
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start29 Jun 2018
- Primary completion27 Apr 2023
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MedulloblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Landi
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Brain Tumor Foundation, Annias Immunotherapeutics, Inc.
- Responsible party
- Sponsor-investigator, Daniel Landi, Duke University
- Investigators
- Daniel Landi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299309
- Sponsor's protocol ID
- Pro00079843
- Acronym
- PRiME
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2017
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
- ClinicalTrials.gov ID
- NCT03299309
- Acronym / sponsor ID
- PRiME / Pro00079843
- Keywords
- Glioma, Medulloblastoma, PRiME, Pro00079843, Thompson, Pediatric, Landi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Daniel LandiUniversity, hospital or other
- Collaborators
- Pediatric Brain Tumor Foundation, Annias Immunotherapeutics, Inc.
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP-CMV | Experimental | Drug: PEP-CMVCytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV) |
Who may qualify
- Ages
- 3 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Patients who are 3 - 35 years old
- Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
- 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.
- Brain MRI within one month prior to enrollment.
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP-CMVAlso: PEP-CMV vaccinePatients 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. | Drug | PEP-CMV |
Primary outcome
Proportion of patients with unacceptable toxicity
Time frame: 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient
Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma
2 secondary outcomes
Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN-γ)
Time frame: 24 months
Mean or median change from baseline at each follow-up assessment in ELISA (gB-KLH)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- The Preston Robert Tisch Brain Tumor Center at DukeLink provided by the sponsor.
- Duke Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Landi, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP-CMV in people with Recurrent Medulloblastoma and Recurrent Brain Tumor, Childhood, run by Daniel Landi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with unacceptable toxicity (time frame: 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.