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

Conditions

• Diffuse Intrinsic Pontine Glioma
• High Grade Glioma
• Recurrent Medulloblastoma

Eligibility Criteria

Sex

ALL

Age

3 Years - 39 Years

Healthy Volunteers

Not accepted

Interventions

• PEP-CMV — BIOLOGICAL
  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.
• Temozolomide — DRUG
  Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1
• Tetanus Diphtheria Vaccine — BIOLOGICAL
  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.

Study Details

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

Key Dates

Start date

Jul 18, 2024

Status verified

Apr 2026

Primary completion

Jun 15, 2028

Completion

Jun 15, 2030

Study Design

Enrollment

120 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: PEP-CMV
  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.

Primary Outcome Measure

4-mo PFS in patients with recurrent medulloblastoma [ Time Frame: 4 months ]

Central Contacts

• Kelsey H Troyer, PhD
  6147223284
  [email protected]

Locations (13)

Find similar trials in Aurora, CO

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