Pro00031169: Poliovirus

Clinical Trials for Adults | Dose-Finding and Safety Study of an Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Glioblastoma


The Study Drug – PVS-RIPO:
PVS-RIPO is a man-made form of the live polio vaccine. Polioviruses, including PVS-RIPO, can attach to and infect malignant glioma cells. Once inside the glioma cell, the PVS-RIPO destroys the cell, which causes an immune response so that other tumor cells can be recognized, flagged, and destroyed by the body’s immune system.

Eligibility: Key Criteria

  • Adults (> 18 years old) with resectable, recurrent supratentorial GBM with measurable disease (≥ 1 cm or ≤ 5 cm of contrast-enhancing tumor).
    • No evidence of diffuse subependymal disease or tumor in the brainstem, cerebellum, spinal cord, or CSF allowed.
    • No radiological evidence of multifocal disease, tumors extending into or crossing the corpus callosum or leptomeningeal disease.
    • Patients with contrast-enhancing tumors of < 1 cm or > 5 cm diameter in any plane will be excluded.
    • Patients with tumor ≤ 1 cm in proximity to the ventricle will be excluded.
  • 4 weeks from any chemotherapy, immunotherapy, investigational therapy, or bevacizumab.
  • Patients must NOT have:
    • Albumin allergy
    • Gadolinium allergy.
    • A history of neurological complications due to poliovirus infection
    • Diagnosis of agammaglobulinemia (IgG levels < 400 mg/dL [4 g/L], undetectable anti-tetanus toxoid IgG, known history of agammaglobulinemia)
  • Patients must have completed all standard of care treatments including resection and concurrent chemo-radiation prior to participating in this trial.

Study Design: Key Features

  • The patient must first receive the polio virus immunization booster.
  • At least two weeks later, the patient will undergo biopsy to confirm diagnosis/recurrence of GBM.  Once diagnosis is confirmed, patient will have a catheter placed for convection-enhanced delivery of the PVS-RIPO.
  • After catheter placement confirmed by CT or MRI, patient to have infusion of PVS-RIPO administered in the ICU over 6.5 hours. Catheter to be removed after infusion is complete. 
  • After the infusion, the patient will follow-up at Duke on weeks 1, 2, 4, 8, and every 8 weeks thereafter.
  • No further treatment is given with this study. 
  • MRIs to be performed at weeks 4 and 8 and then every 8 weeks thereafter.

Potential Side Effects:

  • Gastrointestinal symptoms; diarrhea, gastrointestinal discomfort
  • Fever and flu-like symptoms
  • Symptoms of meningitis (infection of the brain coverings); headache, nausea, vomiting
  • A temporary  or permanent weakness in one or more limbs (legs and arms)
  • A temporary or permanent weakness of the breathing musculature resulting in breathing difficulties
  • Life-threatening breathing difficulties
  • Immune reaction to the study drug with possibly life-threatening complications
  • Brain swelling with possible headache, nausea and vomiting, new or worsening neurological deficit (ability to think, move, feel, speak, see)
  • Potential growth of tumor or exacerbation of the inherent risks and side effect of recurrent glioblastoma.






This article comes from The Preston Robert Tisch Brain Tumor Center at Duke   http://www.cancer.duke.edu/btc
The URL for this story is:   http://www.cancer.duke.edu/btc/modules/ClinicalTrials4/index.php?id=111