A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas … (NCT04573140) | Clinical Trial Compass
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
United States28 participantsStarted 2021-12-13
Plain-language summary
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
Who can participate
Age range4 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Stratum 1 (Adult GBM)
* Age ≥ 21 years.
* Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma, secondary GBM not eligible) that is MGMT low level or unmethylated.
* The tumor must have a supratentorial component.
* 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).
* Residual post-surgical disease burden ≤ 3 cm as defined by longest perpendicular diameter of tumor on post-operative MRI.
* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.
* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.
* Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Bone Marrow:
* ANC (Absolute neutrophil count) ≥ 1,000µl (unsupported)
* Platelets ≥ 150/µl (unsupported for at least 7 days)
* Hemoglobin \> 8 g/dL
* Renal:
* BUN ≤ 25 mg/dl
* Creatinine ≤ 1.7 mg/dl
* Hepatic
* Bilirubin ≤ 2.0 mg/dl
* ALT ≤ 5 times institutional upper limits of normal for age
* AST ≤ 5 ti…
What they're measuring
1
Manufacturing feasibility
Timeframe: from the date of surgery until adminstration of third vaccine, up to 20 weeks
2
Safety of RNA-LP vaccine
Timeframe: First vaccine through 14 days after administration of the 3rd vaccine.