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Cancer Vaccine

PEP-CMV Vaccine for Pediatric Brain Tumor

Phase 2

Recruiting

Led By Maryam Fouladi, MD

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

Must not have

Patients with known immunosuppressive disease are excluded

Patients on dexamethasone > 0.1 mg/Kg/day up to a maximum dose of 4 mg/day or equivalent are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 known immunosuppressive diseases.

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I am not taking more than 4 mg/day of dexamethasone.

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I do not have serious kidney, heart, or lung problems.

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I am not currently on any other cancer treatments.

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I do not have a high risk of sudden worsening in my brain condition according to my MRI.

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I can attend all required follow-up visits and tests.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

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

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

Primary study objectives

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 study objectives

ORR in patients with recurrent medulloblastoma

OS in patients with newly diagnosed HGG by PEP-CMV

PFS in patients with recurrent medulloblastoma

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 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

~1880

0 / 11Eligibility criteria met