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Virus Therapy

Lerapolturev for Glioblastoma

Phase 2
Recruiting
Led By Madison Shoaf, MD
Research Sponsored by Darell Bigner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathologically confirmed recurrent supratentorial glioblastoma (WHO grade 4) (high grade glioma with molecular features of glioblastoma will be eligible)
Karnofsky Performance Score (KPS) ≥ 70%
Must not have
Patients with severe, active co-morbidity, defined as follow: Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C), Patients with known immunosuppressive disease or known human immunodeficiency virus infection, Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4), Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) < 50%) disease or uncontrolled diabetes mellitus, Known albumin allergy, History of agammaglobulinemia, Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from side effects of such therapy, Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy, Patients may not have received treatment with tumor treating fields (e.g., Optune®) ≤ 1 week prior to starting the study drug, Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation, Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.), If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial, If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial, Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease, Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the 1st lerapolturev infusion via CED, Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups), Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin, Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months, Patients with known history of hypersensitivity to lomustine, dacarbazine, or any components of lomustine
Females who are pregnant or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial aims to investigate the safety and effectiveness of giving two doses of lerapolturev within the tumor margins after surgery, followed by repeated injections of lerapolturev under the skin around the lymph

Who is the study for?
Adults over 18 with recurrent high-grade glioblastoma, good performance status (KPS ≥ 70%), and adequate organ function. They must have had prior poliovirus vaccination, be able to undergo MRI scans, and use effective birth control if of childbearing potential. Excluded are pregnant or breastfeeding women, those with severe illnesses like heart disease or uncontrolled diabetes, recent chemotherapy or immunotherapy recipients, and patients on high doses of steroids.
What is being tested?
The trial is testing the safety and effectiveness of lerapolturev injections into residual brain tumor areas after surgery followed by more injections near lymph nodes in the head and neck area. The study also involves taking lomustine pills as part of the treatment regimen for recurrent glioblastoma.
What are the potential side effects?
Potential side effects may include reactions at injection sites, general immune system responses due to vaccine-related components in lerapolturev that could affect various organs, fatigue from treatment procedures, blood count changes due to lomustine pills which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is a confirmed high-grade glioblastoma.
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I am able to care for myself but may not be able to do active work.
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My recurrent tumor was confirmed by a biopsy before starting lerapolturev treatment.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS) - Stage 2
Proportion of patients at each dose level who experienced a dose-limiting toxicity - Stage 1
Proportion of patients who experience an unacceptable toxicity - Stage 2
Secondary study objectives
Progression free survival (PFS)

Side effects data

From 2016 Phase 2 trial • 83 Patients • NCT01067469
39%
ALT/SGPT
17%
anorexia
14%
AST/SGOT
11%
alk phos
6%
Fracture
6%
allergic rhinitis
6%
CNS Ischemia
6%
Confusion
3%
Headache
3%
Perforation, GI
3%
Vessel injury - artery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Bevacizumab
Low Dose Bevacizumab + Lomustine

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Lerapolturev Arm (Stage 2 - Arm 1)Experimental Treatment1 Intervention
Lerapolturev (intratumoral) will be given by Convection Enhanced Delivery (CED), infused twice, 4 days apart, in the remaining disease of recurrent Glioblastoma (rGBM) subjects following maximal safe resection of their disease recurrence. This will be followed by subcutaneous injections of lerapolturev in the cervical perilymphatic (CPL) area on the same side as their tumor, weekly for 4 weeks and afterward every 3 weeks for about a year.
Group II: Lerapolturev Arm (Stage 1)Experimental Treatment1 Intervention
Lerapolturev (intratumoral) will be dosed by Convection Enhanced Delivery (CED), infused twice, 4 days apart, in the remaining disease of recurrent Glioblastoma (rGBM) subjects following maximal safe resection of the disease recurrence. To assess treatment response and/or immunologic responses in the brain, a tissue biopsy of the area infused will be recommended 5 weeks (± 1 week) after the 2nd lerapolturev infusion via CED, in the event that changes suggestive of tumor progression are seen on the MRI obtained 4-5 weeks after the 2nd lerapolturev infusion via CED. .
Group III: Lomustone (Stage 2 Arm 2)Active Control1 Intervention
Following maximal safe resection of their tumor recurrence subjects will receive Lomustine as a single oral dose of 110 mg/m2 every six weeks for up to 9 cycles.

Find a Location

Who is running the clinical trial?

Darell BignerLead Sponsor
7 Previous Clinical Trials
225 Total Patients Enrolled
Istari Oncology, Inc.Industry Sponsor
12 Previous Clinical Trials
327 Total Patients Enrolled
1 Trials studying Supratentorial Glioblastoma
30 Patients Enrolled for Supratentorial Glioblastoma
Madison Shoaf, MDPrincipal InvestigatorDuke University
~61 spots leftby Feb 2029
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