RecruitingRecurrent Medulloblastoma

RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)

Eligible age

4–39 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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 pediatric patients with recurrent/progressive Medulloblastoma (MB)

Sponsor: University of Florida

You may qualify if…

✓ Age \> 3 and \</= 39 years.
✓ Histologically confirmed or suspected recurrent/progressive MB in first or second relapse.
✓ Patients must have received radiation therapy as part of prior therapy.
✓ 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 Therapy: Patients must have fully recovered from all acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
✓ XRT/External Beam Irradiation, including Protons: ≥ 90 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis.
✓ Other therapeutic clinical trials: ≥ 14 days after last dose of investigational agent, unless otherwise defined above.
✓ Patients must not have received prior exposure to pp65-directed therapy or any RNA-LP therapy.

You may not qualify if…

✕ Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+
✕ Bulky disease, defined as:
✕ Tumor with evidence of clinically significant uncal herniation, midline shift, tonsillar herniation, or brainstem infiltration, or that shows significant mass effect in either brain or spine
✕ Tumor with extensive and diffuse multilobular involvement (\>3 lobes)
✕ Tumor with extracranial disease (with the exception of spinal metastases in Stratum 3)
✕ Known HIV, Hepatitis B, or Hepatitis C seropositive.
✕ Uncontrolled seizure disorder
✕ History of myocarditis

Where it's recruiting

Florida

Gainesville

Source: ClinicalTrials.gov · NCT07492316 · last updated 2026-06-29