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A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM) — PNOC020  

Adult Glioblastoma Clinical Trial

Official title:
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)

Clinical Trial 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 unmethylated). Funding Source - FDA OOPD

Clinical Trial Description

This is a first in human Phase I study of RNA-LP vaccines for newly diagnosed adult MGMT unmethylated glioblastoma (GBM). The phase I portion of the study will involve a dose-escalation study to identify the maximally tolerated dose (MTD). Up to 28 participants may be enrolled. 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04573140
Study type Interventional
Source University of Florida
Contact Marcia Hodik
Phone 352-273-6971
Email marcia.hodik@neurosurgery.ufl.edu
Status Recruiting
Phase Phase 1
Start date October 26, 2021
Completion date July 31, 2027
View Details
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