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
Age ≥ 21 years.
Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma, secondary GBM not eligible) that is MGMT low level or unmethylated.
The tumor must have a supratentorial component.
Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).
Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
MGMT Methylated tumors
Gliomatosis Cerebri
Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
University of Florida
Lead sponsor
Pediatric Neuro-Oncology Consortium
Collaborator
University of California, San Francisco
Collaborator
CureSearch
Collaborator
Team Jack Foundation
Collaborator
Florida Department of Health
Collaborator
Food and Drug Administration (FDA)
Collaborator