Study on RNA-Lipid Particle Vaccines for Newly Diagnosed High-Grade Brain Tumors in Children and Adults

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04573140

Provider View

This clinical trial is testing a new type of vaccine, called RNA-Lipid Particle (RNA-LP) vaccines, to see if they are safe and effective for treating newly diagnosed high-grade brain tumors in children and adults. The study aims to find the best dose and ensure the vaccines can be made safely.

Patient Parameters

Program Overview

The main goal of this study is to test the safety and find the best dose of RNA-LP vaccines for treating newly diagnosed high-grade brain tumors in children and adults. The study will include adults with a specific type of brain tumor called glioblastoma (GBM) and children with high-grade gliomas (pHGG). The study is funded by the FDA's Office of Orphan Products Development (OOPD).

Description

This is a Phase I study, which means it's the first time these RNA-LP vaccines are being tested in humans. The study will include up to 28 adults with newly diagnosed glioblastoma (GBM) and 24 children with high-grade gliomas (pHGG). The study will help determine the safest and most effective dose of the vaccine.

The trial has three main parts: surgery, radiation, and immunotherapy. Surgery and radiation are standard treatments for these types of brain tumors. Participants will have their tumor tissue collected during surgery, which will be used to make the RNA-LP vaccines. These vaccines will be given after surgery and radiation.

Participants will receive three RNA-LP vaccines every two weeks, followed by monthly vaccines for up to 14 months, totaling 15 vaccines. The study will monitor participants' health and tumor progression with regular MRI scans and clinical evaluations every three months for the first year and then every 6-12 months for the next two years.

Eligibility Criteria

Exclusion Criteria

For Adults:

  • Cannot have had another invasive cancer in the last 3 years, except for certain skin cancers.
  • Tumors must not have certain genetic markers or be located in specific areas of the brain.
  • Cannot have recurrent or multiple brain tumors.
  • Cannot have large remaining tumor after surgery.
  • Cannot have certain infections or be on high doses of steroids.
  • Cannot have had certain previous cancer treatments.
  • Cannot have severe heart, lung, liver, or immune system conditions.
  • Cannot be pregnant or breastfeeding.
  • Cannot have certain neurological conditions.
  • Cannot be in another clinical trial within 30 days before this study.

For Children:

  • Cannot have certain types of brain tumors or genetic markers.
  • Cannot have large remaining tumor after surgery.
  • Cannot have certain infections or uncontrolled seizures.
  • Cannot have severe heart, lung, liver, or kidney conditions.
  • Cannot be pregnant or breastfeeding.
  • Cannot be in another clinical trial within 30 days before this study.

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