30 Participants Needed

PEP-CMV Vaccine for Recurrent Brain Tumor

(PRiME Trial)

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Daniel Landi, MD profile photo
Overseen ByDaniel Landi, MD
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 | Neuro-oncologist ...

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

My kidney function, measured by creatinine, is within normal range.
I was previously diagnosed with a serious brain tumor.
I can care for myself but may not be able to do active work.
See 10 more

Exclusion Criteria

I do not have any serious illnesses unrelated to my cancer.
I have active kidney, heart, or lung disease.
I am taking medication to suppress my immune system for another health issue.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Initial phase: 6 weeks, then monthly for up to 10 years
3 visits (every 2 weeks), then monthly visits

Follow-up

Participants are monitored for safety and immune response effectiveness after treatment

24 months

Treatment Details

Interventions

  • PEP-CMV
Trial Overview PEP-CMV vaccine is being tested for safety in this study. It's designed for patients whose pediatric brain tumors have come back after initial treatments. The vaccine includes a synthetic peptide aimed at stimulating the immune system to fight the tumor.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PEP-CMVExperimental Treatment1 Intervention
Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eric Thompson, M.D.

Lead Sponsor

Trials
2
Recruited
60+

Gary Archer Ph.D.

Lead Sponsor

Trials
12
Recruited
290+

Daniel Landi

Lead Sponsor

Trials
2
Recruited
30+

Pediatric Brain Tumor Foundation

Collaborator

Trials
2
Recruited
80+

Annias Immunotherapeutics, Inc.

Collaborator

Trials
2
Recruited
60+
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