Lerapolturev for Recurrent Glioblastoma
This study is testing a treatment called lerapolturev for adults with recurrent glioblastoma (a type of brain cancer that has come back). Researchers want to see how safe and effective lerapolturev is when given directly into the tumor after surgery. Some patients will also receive the chemotherapy drug lomustine. The study aims to find out how many patients experience side effects and how long patients live after treatment. You may be able to join if you are 18 or older, have recurrent glioblastoma, and a good performance score (Karnofsky Performance Score ≥ 70%). The study is currently unclear on its recruitment status and plans to enroll 92 participants.
- Study design
- This is an interventional study with two stages. Stage 1 will assess safety in about 12 patients, and Stage 2 will be a randomized comparison of lerapolturev and lomustine in about 80 patients.
- What's involved
- Participants will receive lerapolturev directly into the tumor twice, four days apart. If randomized to lomustine, you will take a pill every six weeks for up to nine cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Patients will be followed for up to one year to monitor for side effects, and for overall survival for up to two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Lerapolturev (PVSRIPO) in GBM
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Madison Shoaf, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- Proportion of patients at each dose level who experienced a dose-limiting toxicity - Stage 1Up to 1 year
Dose-limiting toxicities (DLTs) are defined as any of the following events that are possibly, probably, or definitely attributable to study treatment (i.e., lerapolturev) during dose escalation (Stage 1): * Any Grade 3 or any Grade 4 toxicity within 2 weeks, including cerebral edema or worsening neurologic symptoms * Any life-threatening event within 2 weeks * Treatment-related death at least possibly, probably, or definitely attributable to study treatment * Any grade 2 or higher serious cytokine release syndrome at least possibly, probably, or definitely attributable to study treatment, particularly those affecting vital organs (e.g., cardiac, hepatic, renal, CNS) occurring within 2 weeks of the infusion
- Proportion of patients who experience an unacceptable toxicity - Stage 2Up to 1 year
Unacceptable toxicity is defined as any of the following events that are possibly, probably, or definitely attributable to study treatment: * Any Grade 3 or any Grade 4 toxicity within 2 weeks, including cerebral edema or worsening neurologic symptoms * Any life-threatening event within 2 weeks * Treatment-related death at least possibly, probably, or definitely attributable to study treatment * Any grade 2 or higher serious cytokine release syndrome at least possibly, probably, or definitely attributable to study treatment, particularly those affecting vital organs (e.g., cardiac, hepatic, renal, CNS) occurring within 2 weeks of the infusion
- Overall survival (OS) - Stage 22 years
Median OS, where OS is defined as the time between randomization and death