RecruitingPhase 2NCT06177964

Lerapolturev (PVSRIPO) in GBM

Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma (GBM)


Sponsor

Darell Bigner

Enrollment

92 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing lerapolturev (also called PVSRIPO) — a modified poliovirus injected directly into the brain tumor — for people with recurrent glioblastoma (the most aggressive and deadly brain cancer) that has come back after standard treatment, including surgery, radiation, and chemotherapy. **You may be eligible if...** - You are 18 or older with confirmed recurrent glioblastoma (brain tumor) that has come back after prior treatment - You have a good performance score (Karnofsky 70% or higher) - You have adequate blood counts, kidney, and liver function - Your tumor is located in the cerebral hemispheres (not the brainstem) and is accessible for injection **You may NOT be eligible if...** - You have not yet tried standard treatments like surgery, radiation, and temozolomide chemotherapy - You have known allergy to polio vaccine - You have received a polio booster vaccine within the past year (you would need to get one before enrolling) - Your tumor involves the brainstem or other areas that cannot be safely accessed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLerapolturev

Lerapolturev (intratumoral) will be dosed at 2x108 TCID50 in 3.0 mL x 2 doses (total dose 4x108 TCID50) by Convection Enhanced Delivery. For the patients randomized to the lerapolturev Arm 1 of Stage 2, seven days (±2 days) following completion of the 2nd intratumoral infusion of lerapolturev, patients will begin cervical perilymphatic subcutaneous injection of lerapolturev at a dose of 2 x 108 TCID50 (in 0.5 ml diluent) around the cervical lymph node chain ipsilateral to the intracranial tumor.

DRUGLomustine Pill

Lomustine will be given as a single oral dose of 110 mg/m2 every six weeks for up to 9 cycles.


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT06177964


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