Actively Recruiting
Lerapolturev (PVSRIPO) in GBM
Led by Darell Bigner · Updated on 2025-08-17
92
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
D
Darell Bigner
Lead Sponsor
I
Istari Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 glioblastoma molecular features
- Karnofsky Performance Score of 70% or higher
- Hemoglobin of at least 9 g/dl before biopsy
- Platelet count of at least 100,000/µl to join study; at least 125,000/µl required for biopsy and catheter insertion (may use platelet transfusion)
- Neutrophil count of at least 1000 before biopsy
- Creatinine no more than 1.5 times normal before biopsy
- Total bilirubin no more than 1.5 times upper limit of normal (ULN) before biopsy; up to 3.0 times ULN if Gilbert's Syndrome is diagnosed
- AST/ALT no more than 2.5 times ULN
- Prothrombin and Partial Thromboplastin Times no more than 1.2 times normal before biopsy
- Confirmed presence of recurrent tumor by biopsy before first lerapolturev infusion
- Able to undergo brain MRI with and without contrast
- Completed CDC-recommended polio vaccination series plus booster 1 to 6 weeks before lerapolturev administration or provide evidence of anti-PV immunity
- Patient or partner is either non-childbearing or agrees to use approved birth control methods
- Signed informed consent after understanding study nature
You will not qualify if you...
- Pregnant or breastfeeding females
- Patients with life-threatening brain herniation
- Active severe infections or unexplained fever
- Known immunosuppressive diseases including HIV
- Severe heart disease (NYHA Class 3 or 4), lung disease (FEV1 < 50%), or uncontrolled diabetes
- Allergy to albumin
- History of agammaglobulinemia
- Received chemotherapy or bevacizumab within 4 weeks before study (except specified exceptions)
- Received immunotherapy within 4 weeks before study
- Received tumor treating fields therapy within 1 week before study
- Less than 12 weeks from radiation therapy unless disease progression confirmed
- Not completed all standard care treatments (surgery and radiation)
- Tumors in brainstem, cerebellum, spinal cord, or active multifocal disease
- Using more than 4 mg daily dexamethasone within 2 weeks before first infusion
- Worsening steroid myopathy
- Prior unrelated malignancy needing active treatment (exceptions apply)
- Active autoimmune disease needing systemic immunomodulatory treatment within past 3 months
- Known allergy to lomustine, dacarbazine, or components of lomustine
AI-Screening
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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
CONTACT
S
Stevie Threatt
CONTACT
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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