RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
ConditionRecurrent Medulloblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-39
SponsorUniversity of Florida
About this trial
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)
Eligibility criteria
Qualifiers
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).
Disqualifiers
Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+
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)
Trial design
Treatments tested in this trial
- Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Florida
Lead sponsor
Pediatric Neuro-Oncology Consortium
Collaborator
Source ClinicalTrials.gov