Actively Recruiting
RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
Led by University of Florida · Updated on 2026-04-28
24
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
P
Pediatric Neuro-Oncology Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 3 years and up to 39 years
- Histologically confirmed or suspected recurrent/progressive Medulloblastoma in first or second relapse
- Prior radiation therapy received as part of treatment
- Sterile collection of tumor material suitable for RNA extraction and loading into lipid particles
- Fully recovered from acute toxic effects of prior cancer therapies with required minimum waiting periods
- No prior exposure to pp65-directed therapy or RNA-LP therapy
- Preoperative brain and spine MRI within 28 days before enrollment and postoperative MRI within 7 days after surgery
- Karnofsky score of 60 or higher for participants older than 16 years, Lansky score of 60 or higher for participants younger than 16 years
- Adequate bone marrow function (ANC ≥ 1,000/μl, platelets ≥ 100/μl unsupported for at least 7 days, hemoglobin > 8 g/dL)
- Adequate kidney function (creatinine clearance or GFR ≥ 70 mL/min/1.73 m2)
- Adequate liver function (bilirubin ≤ 3 times upper limit, ALT and AST ≤ 5 times upper limit)
- Stable or decreasing corticosteroid dose for more than 1 week prior to enrollment, with dose limits
- Willingness to take antiepileptic medication like levetiracetam during vaccinations
- Ability to understand and sign informed consent
- Negative pregnancy test at enrollment for women of childbearing potential
- Willingness to use contraception during the study and for 24 weeks after last dose
- Stable neurological deficits for at least 1 week prior to enrollment
- Enrollment in PNOC COMP if available at the institution
You will not qualify if you...
- Diagnosis of diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E positive tumors
- Bulky disease with significant brain or spine mass effect, extensive multilobular involvement (>3 lobes), or extracranial disease except spinal metastases in certain cases
- Known HIV, Hepatitis B, or Hepatitis C infection
- Uncontrolled seizure disorder
- History of myocarditis
- Receipt of any live vaccine within 30 days prior to enrollment
- Known active infection or immunosuppressive disease
- Significant organ dysfunction including renal, cardiac, pulmonary, or hepatic impairment
- Severe or unstable concurrent medical conditions
- Pregnancy or breastfeeding
- Use of other investigational agents or therapeutic protocols within 30 days prior to enrollment
- Inability or unwillingness to receive treatment and complete follow-up evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UF Health Shands Children's Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
E
Elias Sayour, MD, PhD
CONTACT
J
Jannerfer An
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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