← Back to Search

Cancer Vaccine

PEP-CMV Vaccine for Recurrent Brain Tumor (PRiME Trial)

Phase 1

Waitlist Available

Led By Eric Thompson, MD

Research Sponsored by Eric Thompson, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Renal: Serum creatinine ≤ upper limit of institutional normal

Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma

Must not have

Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction)

Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

This trial is testing the safety of a new vaccine for people with brain tumors that have come back after treatment. The vaccine is made from a protein found in the virus that causes chickenpox.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions to vaccines such as soreness at injection site, fever, fatigue and allergic responses. Given it's an investigational therapy targeting the immune system, there could also be inflammation-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function, measured by creatinine, is within normal range.

Select...

I was previously diagnosed with a serious brain tumor.

Select...

I had treatment for my initial diagnosis or can't have radiation due to a genetic risk.

Select...

My liver function tests are within the required limits.

Select...

I am between 3 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious illnesses unrelated to my cancer.

Select...

I have active kidney, heart, or lung disease.

Select...

I am taking medication to suppress my immune system for another health issue.

Select...

I have a fever or infection that needs treatment.

Select...

I can attend all required follow-up visits and tests for therapy side effects.

Select...

I am taking more than 4 mg/day of corticosteroids.

Select...

I have an immunosuppressive disease or HIV.

Select...

I need radiotherapy for my recurring brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with unacceptable toxicity

Secondary study objectives

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

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

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

Acute pulmonary embolism and acute deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Trial Design

1Treatment groups

Experimental Treatment

Group I: PEP-CMVExperimental Treatment1 Intervention

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eric Thompson, M.D.Lead Sponsor

1 Previous Clinical Trials

27 Total Patients Enrolled

Gary Archer Ph.D.Lead Sponsor

11 Previous Clinical Trials

262 Total Patients Enrolled

Daniel LandiLead Sponsor

1 Previous Clinical Trials

3 Total Patients Enrolled

~4 spots leftby Sep 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.