Health TrialsbyHealthPanel

Lerapolturev (PVSRIPO) in GBM

ConditionRecurrent Supratentorial Glioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDarell Bigner

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old at the time of entry into the study.

Histopathologically confirmed recurrent supratentorial glioblastoma (WHO grade 4) (high grade glioma with molecular features of glioblastoma will be eligible).

Karnofsky Performance Score (KPS) ≥ 70%

Hemoglobin ≥ 9 g/dl prior to biopsy

Disqualifiers

Females who are pregnant or breast-feeding

Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lerapolturev

    Drug

    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.

  • Lomustine Pill

    Drug

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

Treatment groups

92 Participants
are divided into 3 treatment groups
Group A: Lerapolturev Arm (Stage 1)Experimental treatment 1 intervention
Group B: Lerapolturev Arm (Stage 2 - Arm 1)Experimental treatment 1 intervention
Group C: Lomustone (Stage 2 Arm 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients at each dose level who experienced a dose-limiting toxicity - Stage 1

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

Time frame
Up to 1 year
2

Proportion of patients who experience an unacceptable toxicity - Stage 2

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

Time frame
Up to 1 year
3

Overall survival (OS) - Stage 2

Median OS, where OS is defined as the time between randomization and death

Time frame
2 years

Secondary outcomes

1

Progression free survival (PFS)

Median PFS, where PFS is defined as the time between randomization and initial failure (disease progression or death)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Darell Bigner

Lead sponsor

Duke University

Sponsor institution

Istari Oncology, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now