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) for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma+1 More
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) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and feasibility of a new vaccine for brain cancer.

Eligible Conditions
  • Glioblastoma

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: up to 30 months

Day 14
Safety of RNA-LP vaccine
Week 20
Manufacturing feasibility
up to 30 months
Determination of Maximum Tolerated Dose

Trial Safety

Trial Design

1 Treatment Group

Phase I adult (Stratum 1)
1 of 1
Experimental Treatment

28 Total Participants · 1 Treatment Group

Primary Treatment: 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) · No Placebo Group · Phase 1

Phase I adult (Stratum 1)
Biological
Experimental Group · 1 Intervention: 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) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 months

Who is running the clinical trial?

CureSearchUNKNOWN
1 Previous Clinical Trials
54 Total Patients Enrolled
University of California, San FranciscoOTHER
2,262 Previous Clinical Trials
11,470,076 Total Patients Enrolled
15 Trials studying Glioblastoma
1,005 Patients Enrolled for Glioblastoma
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
767 Total Patients Enrolled
4 Trials studying Glioblastoma
157 Patients Enrolled for Glioblastoma
University of FloridaLead Sponsor
1,236 Previous Clinical Trials
697,007 Total Patients Enrolled
10 Trials studying Glioblastoma
450 Patients Enrolled for Glioblastoma
Elias Sayour, MD, PhDStudy ChairUniversity of Florida
2 Previous Clinical Trials
31 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have residual disease after surgery for a glioma of any size.
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).
ANC > 1,500µl (unsupported).
You have a platelet count of at least 150/µl.
You have recovered from the effects of surgery, postoperative infection, and other complications.
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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.