← Back to Search

Cancer Vaccine

RNA-LP Vaccine for Glioblastoma (PNOC020 Trial)

Phase 1 & 2

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

Must not have

Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement

Metastatic or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 21 years old or older.

Select...

My tumor is located in the upper part of my brain.

Select...

My liver function tests are within the required limits.

Select...

My remaining cancer is smaller than 3 cm after surgery.

Select...

I can take care of myself but may not be able to work or do heavy physical activities.

Select...

My brain tumor is a new, high-grade type and has not been treated before.

Select...

My kidney tests for BUN and creatinine are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to the brain or beyond.

Select...

My cancer has spread to other parts of my body or the lining of my brain and spinal cord.

Select...

I have an active infection or a disease that weakens my immune system.

Select...

I have been diagnosed with Gliomatosis Cerebri.

Select...

My brain tumor has come back or is found in multiple places.

Select...

My cancer is larger than 3 cm after surgery, as shown on an MRI.

Select...

My tumor is MGMT methylated.

Select...

I have had radiation therapy to my head or neck that overlaps with previous treatments. Radiosurgery was not used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of Maximum Tolerated Dose

Manufacturing feasibility

Safety of RNA-LP vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase I pediatric (Stratum 2)Experimental Treatment1 Intervention

A maximum of 24 adult patients will be enrolled in dose-escalation study using 3+3 study design.

Group II: 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).

0 / 15Eligibility criteria met