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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

PRiME Trial 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.Check my eligibility
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.See study design
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.

PRiME Trial 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.

PRiME Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with unacceptable toxicity
Secondary outcome measures
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 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

PRiME 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the fatality rate of PEP-CMV?

"While there is only limited data backing PEP-CMV's safety and efficacy, it still received a score of 1."

Answered by AI

What is the cap on the number of people who can join this research project?

"That is correct, the information available on clinicaltrials.gov does show that this trial is looking for more participants. The listing says that the trial was posted on 6/29/2018 and edited most recently on 6/7/2022. They are hoping to enroll 30 patients from 1 site."

Answered by AI

Are there specific inclusion criteria for participants in this test?

"Eligible participants for this clinical trial must have glioma and be between the ages of 3-35. The study will admit around 30 individuals in total."

Answered by AI

Could people who are under 55 years old participate in this experiment?

"According to the eligibility requirements for this study, 3-35 year olds are able to enroll."

Answered by AI

Are we still able to enroll patients in this clinical trial?

"The study, which clinicaltrials.gov has listed as presently seeking patients, was first posted on 6/29/2018 and last updated on 6/7/2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Daniel Landi 2018. "PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03299309.
All > Cmv > Medulloblastoma
~4 spots leftby Apr 2025
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