Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

This phase II clinical trial will have 3 strata in order to assess the efficacy of a highly immunogenic CMV-directed peptide vaccines in children with (1) recurrent medulloblastoma (rMB), (2) newly-diagnosed high-grade gliomas (HGG) and (3) newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Each stratum will run independently with a different endpoint and statistical design. Within each stratum, the populations that may be used for analysis are defined as: - Safety Analysis: Patients who receive at least 1 dose of the treatment will be used for safety analyses. - Efficacy Analysis: Patients who receive at least 1 dose of the treatment will be used for efficacy analyses. Stratum I: Patients with recurrent medulloblastoma with measurable disease (see eligibility) can be enrolled at any point following recurrence regardless of any prior therapy. For the purpose of this study, recurrence will be defined as a new lesion confirmed by biopsy or resection, positive cerebrospinal fluid (CSF) cytology, or recurrent/progressive tumor on MRI. Strata II and III: Patients with newly-diagnosed high-grade glioma or DIPG may be enrolled any time within 42 days after completing radiation. Cycle 1 (Induction cycle) is 77±2 days. Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1 and receive PEP-CMV vaccine intradermally at dose level 1 (250 μg/m2 ) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle which is 77 ± 2 days, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered intradermally every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days for a total of 24 cycles. 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. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05096481
Study type Interventional
Source Nationwide Children's Hospital
Contact Leonie Mikael, PhD
Phone 6147223284
Email LEONIE.MIKAEL@NATIONWIDECHILDRENS.ORG
Status Not yet recruiting
Phase Phase 2
Start date June 15, 2024
Completion date June 15, 2030

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05023551 - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Completed NCT01466686 - Low Dose Radiation Therapy for Glioblastoma Multiforme Phase 2
Recruiting NCT05925218 - Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Recruiting NCT05212272 - MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Recruiting NCT04734444 - SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue N/A
Completed NCT03775369 - Glioma and Exercising N/A
Completed NCT02022644 - Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma Phase 1
Completed NCT00780819 - Borderzone Sampling N/A
Recruiting NCT06072586 - Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions Early Phase 1
Completed NCT01390948 - A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Phase 2
Recruiting NCT03952598 - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy N/A
Recruiting NCT05630664 - Liquid Biopsy in High-grade Gliomas and Meningiomas
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1
Completed NCT01222754 - Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT05278208 - Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors Phase 1/Phase 2