RecruitingPhase 2NCT05096481

PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

Phase 2 Trial of a Novel Peptide Vaccine (PEP-CMV) Targeting CMV Antigen for Newly Diagnosed Pediatric High-grade Glioma and Diffuse Intrinsic Pontine Glioma and Recurrent Medulloblastoma


Sponsor

Nationwide Children's Hospital

Enrollment

120 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD


Eligibility

Min Age: 3 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a vaccine (called PEP-CMV) that targets a protein from the cytomegalovirus (CMV) found in brain tumor cells. It is being tested in children and young adults with newly diagnosed high-grade brain tumors (HGG/DIPG) or with recurrent medulloblastoma — a type of brain cancer. **You may be eligible if...** - You are between 3 and 39 years old - You have been diagnosed with recurrent or progressive medulloblastoma with a measurable tumor on MRI, OR you have a newly diagnosed high-grade brain tumor (HGG) or DIPG - You have already received prior radiation and other standard therapies - Your performance/functional status meets minimum requirements **You may NOT be eligible if...** - Your tumor does not have the CMV protein that the vaccine targets - You have severe organ dysfunction - You are pregnant or breastfeeding - You have active uncontrolled infection - Your prior radiation was completed too recently (within the required washout period) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPEP-CMV

The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.

DRUGTemozolomide

Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1

BIOLOGICALTetanus Diphtheria Vaccine

Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.


Locations(12)

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Duke Cancer Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05096481


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