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

Recruiting now · Phase 1

Conditions studied: Adult Glioblastoma, High Grade Glioma, WHO Grade III or IV Malignant Glioma

In brief

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

Key facts

Study ID

NCT04573140

Run by

University of Florida

People needed

28

Starts

2021-12-13

Expected to finish

2029-07-01

Last updated by the study team

2026-06-25

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Stratum 1 (Adult GBM)
• 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.
• Recurrent or multifocal malignant gliomas.
• Metastatic or leptomeningeal disease
• Residual post-surgical disease burden > 3 cm as defined by longest perpendicular diameter on MRI.
• Known HIV, Hepatitis B, or Hepatitis C seropositive.
• Known active infection or immunosuppressive disease.
• Participants who require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination.
• Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region, other than TMZ prescribed during radiation for GBM (prior chemotherapy for a different cancer is allowable).
• Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. Radiosurgery is not permitted.
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization.
• Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of XRT/TMZ.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
• Patients with autoimmune disease requiring medical management with immunosuppressants.
• Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
• Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.
• Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Women of childbearing potential must not be pregnant or breast-feeding.

Where it is running

• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• UF Health — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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