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Cancer Vaccine
RNA-LP Vaccine for Glioblastoma (PNOC020 Trial)
Phase 1
Recruiting
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >/= 21 years
The tumor must have a supratentorial component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
PNOC020 Trial Summary
This trial will test the safety and feasibility of a new vaccine for brain cancer.
Who is the study for?
This trial is for adults over 21 with newly diagnosed GBM (a type of brain tumor) that hasn't spread, and whose tumors are not responsive to certain DNA repair mechanisms (MGMT unmethylated). Participants must be in good health post-surgery, have adequate organ function, and agree to use contraception. Those with prior treatments for head/neck cancer or other invasive malignancies within the last 3 years, active infections or immune diseases, severe medical conditions, or who are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests RNA-LP vaccines made from a patient's own tumor mRNA against GBM. It aims to find the highest dose patients can tolerate without serious side effects (MTD), ensure it's safe to make and give these vaccines intravenously. The vaccine is designed to teach the body’s immune system to recognize and attack the tumor.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, flu-like symptoms including fever and chills, fatigue, headache, muscle aches. Since this is an investigational treatment assessing safety and MTDs isn't fully known yet.
PNOC020 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
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My tumor is located in the upper part of my brain.
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My liver function tests are within the required limits.
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My remaining cancer is smaller than 3 cm after surgery.
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I can take care of myself but may not be able to work or do heavy physical activities.
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My brain tumor is a new, high-grade type and has not been treated before.
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My kidney tests for BUN and creatinine are within normal limits.
PNOC020 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of Maximum Tolerated Dose
Manufacturing feasibility
Safety of RNA-LP vaccine
PNOC020 Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase I adult (Stratum 1)Experimental Treatment1 Intervention
A maximum of 28 adult patients will be enrolled in dose-escalation study using the BOIN design with an initial embedded accelerated titration design (ATD).
Find a Location
Who is running the clinical trial?
Team Jack FoundationUNKNOWN
1 Previous Clinical Trials
44 Total Patients Enrolled
Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,975 Total Patients Enrolled
CureSearchUNKNOWN
1 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have given or my legal representative has given consent for me to participate.I agree to use approved birth control methods during and for 24 weeks after the study.My neurological condition has been stable for at least a week.I am 21 years old or older.My tumor is located in the upper part of my brain.My cancer has spread to the brain or beyond.My cancer has spread to other parts of my body or the lining of my brain and spinal cord.My liver function tests are within the required limits.I have had radiation therapy to my head or neck that overlaps with previous treatments. Radiosurgery was not used.I have been cancer-free for over 3 years, except for non-dangerous skin cancers.I am taking high doses of corticosteroids and cannot reduce to normal levels within a week.I have not had chemotherapy or radiosensitizers for head/neck cancer, except for TMZ with GBM radiation.I have an active infection or a disease that weakens my immune system.My remaining cancer is smaller than 3 cm after surgery.I can take care of myself but may not be able to work or do heavy physical activities.My brain tumor is a new, high-grade type and has not been treated before.I have been diagnosed with Gliomatosis Cerebri.My brain tumor has come back or is found in multiple places.My cancer is larger than 3 cm after surgery, as shown on an MRI.My tumor is MGMT methylated.I have fully recovered from any surgery or its complications.I've had or will have a brain MRI before and after surgery, matching in type, within the specified times.My kidney tests for BUN and creatinine are within normal limits.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I adult (Stratum 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved 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)?
"There is limited evidence in support of the safety and effectiveness of Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously, earning it a score of 1."
Answered by AI
How many individuals are partaking in this clinical investigation?
"Affirmatively, clinicaltrials.gov has ascertained that this research is actively searching for patients to partake in the trial. This study was first advertised on October 26th 2021 and its parameters were most recently modified on August 30th 2022; 28 individuals must be recruited from one medical site."
Answered by AI
Are new participants being admitted into this clinical experiment?
"According to clinicaltrials.gov, this experiment is presently welcoming participants. It was initially posted on October 26th 2021 and had its most recent amendment made on August 30th 2022."
Answered by AI
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