Lerapolturev (PVSRIPO) in GBM
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
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
Treatments tested in this trial
- Lerapolturev
- Lomustine Pill
Treatment groups
92 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov