Actively Recruiting
Randomized Phase 2 Clinical Trial Comparing Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma
Led by Darell Bigner · Updated on 2025-08-17
92
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Darell Bigner
Lead Sponsor
I
Istari Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of lerapolturev in adults with recurrent supratentorial glioblastoma, a type of brain tumor. The study is conducted in two stages, including a safety lead-in and a randomized phase 2 clinical trial comparing lerapolturev with the chemotherapy drug lomustine. The purpose is to determine how well lerapolturev works when given as repeated injections after surgery and to monitor related side effects and outcomes. In the first stage, about twelve patients receive two doses of lerapolturev infused directly into the remaining tumor area four days apart using Convection Enhanced Delivery (CED). If imaging suggests tumor progression, a tissue biopsy is recommended five weeks after the second infusion. In the second stage, around eighty patients are randomly assigned to receive either lerapolturev or lomustine after tumor removal. Those on lerapolturev get the same two CED infusions followed by weekly subcutaneous injections near the lymph nodes in the neck for four weeks, then every three weeks for up to a year. Patients assigned to lomustine take oral doses every six weeks for up to nine cycles. Participants will undergo regular brain MRIs and evaluations to monitor tumor response and side effects. Researchers will track safety outcomes for up to a year and overall survival for two years. Medical records will be reviewed over the participants' lifetimes to collect information on treatments, tumor progression, and survival. The study also monitors for adverse events related to the treatments and procedures throughout the trial and follow-up periods.
CONDITIONS
Brief Title
Lerapolturev (PVSRIPO) in GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at study entry
- Confirmed recurrent supratentorial glioblastoma (WHO grade 4) or high grade glioma with molecular features of glioblastoma
- Karnofsky Performance Score of at least 70%
- Hemoglobin level of 9 g/dl or higher before biopsy
- Platelet count of at least 100,000/µl unsupported (125,000/µl required for biopsy and catheter insertion)
- Neutrophil count of at least 1000 before biopsy
- Creatinine level no greater than 1.5 times the normal range before biopsy
- Total bilirubin no greater than 1.5 times the upper limit of normal (ULN), or up to 3.0 times ULN if Gilbert's Syndrome
- AST/ALT levels no greater than 2.5 times ULN
- Prothrombin and Partial Thromboplastin Times no greater than 1.2 times normal before biopsy
- Confirmed recurrent tumor by histopathology at biopsy before first lerapolturev infusion
- Ability to undergo brain MRI with and without contrast
- Completed CDC-recommended poliovirus vaccination series and booster 1 to 6 weeks before lerapolturev administration
- Agreement to use effective birth control if of childbearing potential
- Signed informed consent form and ability to understand the study
You will not qualify if you...
- Pregnant or breastfeeding females
- Life-threatening cerebral herniation syndrome
- Severe, active co-morbidities including active infection needing IV treatment or unexplained fever
- Known immunosuppressive disease or HIV infection
- Severe heart disease (NYHA Class 3 or 4)
- Known severe lung disease (FEV1 < 50%) or uncontrolled diabetes
- Known allergy to albumin
- History of agammaglobulinemia
- Recent chemotherapy or bevacizumab within 4 weeks (with some exceptions)
- Recent immunotherapy within 4 weeks
- Recent tumor treating fields therapy within 1 week
- Less than 12 weeks since radiation therapy unless specific progression criteria met
- Incomplete standard care treatments including surgery and radiation
- Brainstem, cerebellum, or spinal cord lesions; active multifocal disease; extensive subependymal disease; tumor crossing midline or leptomeningeal disease
- Use of more than 4 mg daily dexamethasone within 2 weeks before first lerapolturev infusion
- Worsening steroid myopathy
- Prior unrelated malignancy requiring active treatment except certain skin or cervical cancers
- Active autoimmune disease needing systemic treatment within past 3 months
- Known hypersensitivity to lomustine, dacarbazine, or lomustine components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo maximal safe resection surgery to remove the recurrent glioblastoma tumor.
1 visit (in-person)
Duration - Up to 1 year
Participants receive one of two treatment regimens after surgery: - For those in the Lerapolturev arm, participants receive two intratumoral infusions of lerapolturev by Convection Enhanced Delivery (CED), 4 days apart, followed by weekly subcutaneous injections into the cervical lymph nodes for 4 weeks and then every 3 weeks for about a year. - For those in the Lomustine arm, participants take a single oral dose of lomustine every 6 weeks for up to 9 cycles or about 1 year.
2 intratumoral infusion visits, then weekly injections for 4 weeks and every 3 weeks thereafter (Lerapolturev arm) or oral dose every 6 weeks (Lomustine arm)
Duration - Up to 2 years or lifetime for medical record review
Participants are monitored for serious adverse events for 30 days after treatment ends. After that, medical record reviews occur for the remainder of their life to collect data on disease progression, treatments, tumor status, and survival.
Periodic medical record reviews; no required visits
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
M
Madison Shoaf, MD
S
Stevie Threatt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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