Lerapolturev in Recurrent Malignant Glioma
- Registration Number
- NCT02986178
- Lead Sponsor
- Istari Oncology, Inc.
- Brief Summary
This is a phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.
- Detailed Description
This is a Phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of lerapolturev in recurrent WHO grade IV malignant glioma.
Patients will be administered lerapolturev intratumorally via convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Retreatment with lerapolturev is allowed, provided retreatment eligibility criteria are met.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lerapolturev lerapolturev lerapolturev administered once intratumorally by convection-enhanced delivery lerapolturev + lomustine lerapolturev lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing lerapolturev + lomustine Lomustine lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
- Primary Outcome Measures
Name Time Method Number of Participants With Objective Radiographic Response up to 5 years Assess objective anti-tumor response based on iRANO criteria.
Duration of Objective Radiographic Response up to 5 years Assess time of confirmed response to confirmed disease progression or death
- Secondary Outcome Measures
Name Time Method Median Overall Survival up to 5 years Overall Survival (months), calculated using the Kaplan-Meier method
Landmark Survival at 24 and 36 months post-lerapolturev infusion Overall survival (months) at 24 and 36 months, calculated using the Kaplan-Meier method
Disease Control Rate up to 5 years the percentage of participants achieving complete response, partial response, or stable disease
Safety of Lerapolturev up to 52 weeks Number of participants experiencing Grade 3, 4 or 5 adverse events considered possibly, probably, or definitely related to protocol treatment
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (6)
UCSF Neurological Surgery
🇺🇸San Francisco, California, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Preston Robert Tisch Brain Tumor Center at Duke University
🇺🇸Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
UCSF Neurological Surgery🇺🇸San Francisco, California, United States