Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04573140
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2020-09-14
Brief Title:
A Study of RNA-lipid Particle RNA-LP Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas pHGG and Adult Glioblastoma GBM
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Phase III Study of RNA-lipid Particle RNA-LP Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas pHGG and Adult Glioblastoma GBM
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:
PNOC020
Brief Summary:
The primary objective will be to demonstrate the manufacturing feasibility and safety and to determine the maximum tolerated dose MTD of RNA-LP vaccines in Stratum 1 adult patients with newly diagnosed GBM MGMT low level or unmethylated in adults only and Stratum 2 in pediatric patients with newly diagnosed HGG pHGG Funding Source - FDA OOPD
Detailed Description:
This is a first in human Phase I study of RNA-LP vaccines for newly diagnosed adult MGMT unmethylated glioblastoma GBM and pediatric patients with newly diagnosed HGG pHGG The phase I portion of the study will involve a dose-escalation study to identify the maximally tolerated dose MTD Up to 28 adult participants and 24 pediatric participants may be enrolled in the Phase I study
This clinical trial will consist of three parts Surgery Radiation and Immunotherapy Surgery and chemoradiation will be standard of care for patients with GBM Potentially eligible participants will be enrolled on a screening consent for the sterile collection of tumor material in a manner suitable for RNA extraction amplification and loading of lipid particles LPs Tumor material will be sent to the University of Florida UF Following surgical resection with confirmatory pathologic diagnosis patients will be enrolled in the trial after informed consent has been obtained
The RNA-LP vaccination will begin within 4 weeks following radiation and after review of post-radiation MRI for baseline After radiation patients will receive three RNA-LP vaccines every 2 weeks before beginning 12 cycles of adjuvant monthly RNA- LP vaccines for a total of 15 vaccines
Participants may receive RNA-LP vaccines for up to 14 months
Participants will be followed until death due to any cause MRI and clinical evaluation for assessment of disease progression will be conducted every 3 months for the first-year post-immunotherapy and then every 6-12 months over the next 2 years
This clinical trial will consist of three parts Surgery Radiation and Immunotherapy Surgery and chemoradiation will be standard of care for patients with GBM Potentially eligible participants will be enrolled on a screening consent for the sterile collection of tumor material in a manner suitable for RNA extraction amplification and loading of lipid particles LPs Tumor material will be sent to the University of Florida UF Following surgical resection with confirmatory pathologic diagnosis patients will be enrolled in the trial after informed consent has been obtained
The RNA-LP vaccination will begin within 4 weeks following radiation and after review of post-radiation MRI for baseline After radiation patients will receive three RNA-LP vaccines every 2 weeks before beginning 12 cycles of adjuvant monthly RNA- LP vaccines for a total of 15 vaccines
Participants may receive RNA-LP vaccines for up to 14 months
Participants will be followed until death due to any cause MRI and clinical evaluation for assessment of disease progression will be conducted every 3 months for the first-year post-immunotherapy and then every 6-12 months over the next 2 years
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 |
|---|---|---|---|
| IRB202001710 | OTHER | None | None |
| R01FD007268-01A1 | FDA | UF IRB-01 | httpsreporternihgovquickSearchR01FD007268-01A1 |