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Cancer Vaccine

PEP-CMV Vaccine for Pediatric Brain Tumor

Phase 2
Waitlist Available
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have measurable disease defined as a lesion that can be measured in two perpendicular diameters on MRI
Patients must meet organ function requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study whether the PEP-CMV vaccine can help treat high-grade glioma, diffuse intrinsic pontine glioma, and recurrent medulloblastoma in children.

Who is the study for?
This trial is for pediatric patients aged 3-25 with high-grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), or recurrent medulloblastoma. They must have a confirmed diagnosis, measurable disease on MRI, and stable neurological deficits if present. Prior radiotherapy is required unless they're under 4 years old.Check my eligibility
What is being tested?
The study tests PEP-CMV vaccine targeting CMV antigens in children with brain tumors like HGG, DIPG, and recurrent medulloblastoma. It explores the potential of this novel immunotherapy approach combined with Temozolomide chemotherapy and Tetanus Diphtheria Vaccine.See study design
What are the potential side effects?
Possible side effects may include typical vaccine reactions such as pain at the injection site, fever, fatigue, headache, muscle or joint pain. Since it's an investigational therapy specific to cancer treatment side effects are monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured on an MRI.
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My organs are functioning well.
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My cancer has spread to other parts of my body.
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My medulloblastoma has come back or is not responding to treatment, confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1-yr OS in patients with newly diagnosed DIPG
1-yr PFS in patients with newly diagnosed HGG
4-mo PFS in patients with recurrent medulloblastoma
Secondary outcome measures
ORR in patients with recurrent medulloblastoma
OS in patients with newly diagnosed HGG by PEP-CMV
PFS in patients with recurrent medulloblastoma

Trial Design

1Treatment groups
Experimental Treatment
Group I: PEP-CMVExperimental Treatment3 Interventions
Participants will receive standard chemotherapy with temozolomide for five days, followed by the study vaccine, PEP-CMV, on day 21. Participants will receive a tetanus diphtheria (Td) booster vaccine and a small dose Td preconditioning vaccine to prepare their immune system to receive their first PEP-CMV vaccine. Participants will receive the first 3 PEP-CMV vaccines every 2 weeks, and after the third vaccine, the rest of the vaccines will be given monthly. The first cycle is 77 days and all subsequent cycles are 28 days. The PEP-CMV vaccine may be received for up to 24 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
337 Previous Clinical Trials
5,220,034 Total Patients Enrolled
Eric Thompson, MDStudy ChairDuke University
2 Previous Clinical Trials
42 Total Patients Enrolled
Daniel Landi, MDStudy ChairDuke University
9 Previous Clinical Trials
217 Total Patients Enrolled

Media Library

PEP-CMV Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05096481 — Phase 2

Frequently Asked Questions

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

Can octogenarians participate in this research project?

"The ages of 3 to 25 are the only patients that will be considered for this trial. In total, there are 345 trials testing medications on children and 1346 studies involving seniors."

Answered by AI

Why is PEP-CMV taken so often?

"PEP-CMV can be used to treat nitrosourea treatment, advance directives, and refractory, advanced mycosis fungoides."

Answered by AI

In how many countries is this trial taking place?

"In total, there are 10 clinical trial sites currently enrolling patients. Some notable locations include Seattle Children's Hospital, Cincinnati Children's Hospital Medical Center, and Children's National Medical Center."

Answered by AI

Does this experiment have any open slots for new participants?

"Unfortunately, this particular clinical trial is not presently looking for new patients. This study was initially posted on 11/15/2022 and last updated on 8/10/2022. There are 1631 other medical trials that are recruiting at this time though."

Answered by AI

Do we have any previous data to compare these PEP-CMV results to?

"There are currently 218 ongoing trials studying PEP-CMV. 25 of these are Phase 3 clinical trials, which is the stage with the most human testing. The majority of these studies take place in Seoul and Songpa, but there are 4,820 total locations running PEP-CMV trials."

Answered by AI

How many test subjects are needed for this experiment?

"This trial is not recruiting at this time, however, there are 1413 other clinical trials actively recruiting participants with diffuse intrinsic pontine glioma and 218 studies for PEP-CMV."

Answered by AI

Which types of patients are best suited for this clinical trial?

"This trial is looking for 120 participants that have diffuse intrinsic pontine glioma and are between the ages of 3-25. Most importantly, patients must meet the following criteria: Karnofsky ≥ 50% for patients >16 years old or Lansky ≥ 50 for patients ≤ 16 years old. Additionally, even if a patient is unable to walk because of paralysis, as long as they can be wheeled around in a chair, they will be considered ambulatory for performance score assessment. For more information, please see Appendix I."

Answered by AI

What sets this clinical trial apart from others?

"PEP-CMV has been researched since 2002 when the first clinical trial was conducted. Sixty people participated in this initial study that was sponsored by Schering-Plough. Based on the results of this 2002 study, PEP-CMV received Phase 2 drug approval. Currently, there are 218 live studies for PEP-CMV being conducted across 947 cities and 36 countries."

Answered by AI

What are the government regulations on PEP-CMV?

"While there is some data supporting PEP-CMV's safety, it has not been proven effective yet and thus received a score of 2."

Answered by AI
~80 spots leftby Apr 2028