Viewing Study NCT05096481



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Last Modification Date: 2024-10-26 @ 2:16 PM
Study NCT ID: NCT05096481
Status: RECRUITING
Last Update Posted: 2024-07-11
First Post: 2021-10-15

Brief Title: PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
Sponsor: Nationwide Childrens Hospital
Organization: Nationwide Childrens Hospital

Study Overview

Official Title: 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
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 wateroil emulsion in Montanide ISA 51

Funding Source - FDA OOPD
Detailed 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 recurrentprogressive 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 772 days Patients will receive one course of temozolomide 200 mgm2day x 5 days on Days 1-5 of cycle 1 and receive PEP-CMV vaccine intradermally at dose level 1 250 μgm2 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 04 mL of saline delivered id 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 µgm2 up to a maximum of 500 µg of Component A mixed with Montanide ISA-51 11 volume ratio intradermally administered half in the RIGHT groin and half in the LEFT groin

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01FD007283 FDA None httpsreporternihgovquickSearchR01FD007283