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Cancer Vaccine

RNA-Lipid Particle Vaccines for Recurrent Glioblastoma

Phase 1

Recruiting

Led By Ashley Ghiaseddin, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be at least 90 days from completion of prior radiation

Any adverse events patient has experienced from prior therapy must have resolved to ≤ Gr. 1 according to CTCAE (NCI Common Terminology Criteria for Adverse Events) v5.0 prior to enrollment

Must not have

Patients with uncontrolled seizure disorders

Known active infection (requiring treatment by antiviral or antibiotics) or immunosuppressive disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first vaccine to 30 days after last dose of vaccine administered, up to 17 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of vaccine for adults with recurrent glioblastoma to see if it can be safely manufactured and determine the highest safe dose.

Who is the study for?

This trial is for adults with recurrent glioblastoma, a type of brain cancer. Participants must have evidence of tumor recurrence after standard treatments. Specific eligibility criteria are not provided here.

What is being tested?

The study is testing two types of RNA-Lipid Particle (RNA-LP) vaccines: pp65 RNA loaded lipid particles (DP1) and another set of RNA loaded lipid particles (DP2). It aims to find the highest dose patients can tolerate without severe side effects.

What are the potential side effects?

Since this is a Phase I trial primarily focused on safety and determining the maximum tolerated dose, specific side effects are not listed but may include typical vaccine-related reactions such as pain at injection site, fever, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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It has been over 90 days since my last radiation treatment.

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Any side effects from my previous treatments have mostly gone away.

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I am not on steroids, or I am on a low, maintenance dose.

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My tumor is located above the cerebellum.

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I had surgery and radiotherapy as my first treatments.

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My liver function tests are within the required limits.

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I am 18 years old or older.

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My brain tumor is a confirmed recurrent GBM according to the latest WHO guidelines.

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I am eligible for surgery or biopsy to collect tumor samples for testing.

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My kidney function tests are within normal limits.

Exclusion Criteria

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

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I have seizures that are not controlled by medication.

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I am currently being treated for an infection or have a disease that weakens my immune system.

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My tumor is located in the brainstem or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first vaccine to 30 days after last dose of vaccine administered, up to 17 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first vaccine to 30 days after last dose of vaccine administered, up to 17 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first vaccine to 30 days after last dose of vaccine administered, up to 17 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

Incidence of investigational treatment related toxicities

Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines

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: Arm 2: pp65 RNA-LPs (DP1) after biopsyExperimental Treatment2 Interventions

Randomized 1:1 to receive pp65 RNA-LPs (DP1) starting after tumor biopsy/resection. All patients will receive three pp65 RNA-LP vaccines (DP1) before receiving full dose monthly RNA-LPs (RNA loaded lipid particles, RNA-LPs, DP2).

Group II: Arm 1: pp65 RNA-LPs (DP1) before biopsyExperimental Treatment2 Interventions

Randomized 1:1 to receive pp65 RNA-LPs (DP1) starting before tumor biopsy/resection. All patients will receive three pp65 RNA-LP vaccines (DP1) before receiving full dose monthly RNA-LPs (RNA loaded lipid particles, RNA-LPs, DP2).

0 / 13Eligibility criteria met