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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
No Placebo-Only Group

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
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My kidney function, measured by creatinine, is within normal range.
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I was previously diagnosed with a serious brain tumor.
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I had treatment for my initial diagnosis or can't have radiation due to a genetic risk.
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My liver function tests are within the required limits.
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I am between 3 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses unrelated to my cancer.
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I have active kidney, heart, or lung disease.
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I am taking medication to suppress my immune system for another health issue.
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I have a fever or infection that needs treatment.
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I can attend all required follow-up visits and tests for therapy side effects.
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I am taking more than 4 mg/day of corticosteroids.
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I have an immunosuppressive disease or HIV.
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I need radiotherapy for my recurring brain tumor.

Timeline

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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PEP-CMVExperimental Treatment1 Intervention
Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV)

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 Nov 2025