Study on Lerapolturev (PVSRIPO) for Recurrent Glioblastoma

Sponsor: Darell Bigner

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06177964

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment called lerapolturev for adults with recurrent glioblastoma, a type of brain cancer. The treatment involves injecting lerapolturev into the tumor area after surgery and under the skin near lymph nodes in the head and neck.

Patient Parameters

Program Overview

The study aims to find out if lerapolturev is safe and can help control recurrent glioblastoma, a type of brain cancer. Patients will receive two doses of lerapolturev directly into the tumor area after surgery, followed by regular injections under the skin near the lymph nodes in the head and neck. The trial is being conducted at the Preston Robert Tisch Brain Tumor Center at Duke.

Description

The study is divided into two stages. In Stage 1, about twelve patients with recurrent glioblastoma will participate to test the safety of lerapolturev. They will receive two doses of the drug, four days apart, directly into the tumor area using a method called Convection Enhanced Delivery (CED). A biopsy may be recommended about five weeks after the second dose to check for changes in the tumor.

Stage 2 involves about eighty patients and compares two treatments: lerapolturev and a chemotherapy drug called lomustine. After surgery to remove the tumor, patients will be randomly assigned to receive either lerapolturev or lomustine. Those receiving lerapolturev will get two doses into the tumor area and then weekly injections under the skin near the lymph nodes for four weeks, followed by injections every three weeks for about a year. Patients on lomustine will take it every six weeks for up to a year.

Participants will be monitored for side effects for 30 days after stopping the study. Medical records will be reviewed to track treatment outcomes and survival. Common side effects of lerapolturev include headache, seizures, and fatigue, while lomustine may affect blood cell counts and liver function.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with recurrent glioblastoma, a type of brain cancer.
  • Have a performance status score of 70% or higher, indicating the ability to carry out daily activities.
  • Meet specific blood count and organ function requirements.
  • Able to undergo MRI scans.
  • Have received a polio vaccine booster before starting the study.
  • Agree to use effective birth control if of childbearing potential.
  • Must sign an informed consent form to participate.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Patients with life-threatening brain conditions or severe active medical issues.
  • Patients with certain infections or immune system diseases.
  • Patients who have recently received other cancer treatments or have not completed standard treatments.
  • Patients with tumors in specific brain areas or with certain types of brain disease.
  • Patients on high doses of steroids or with muscle weakness from steroid use.
  • Patients with other active cancers or autoimmune diseases requiring treatment.
  • Patients allergic to certain chemotherapy drugs.

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