Dose-Finding and Safety Study of an Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Glioblastoma
A clinical trial using PVSRIPO in children is not currently open to enrollment . Our team is working on this approval process. It is not available through expanded access (compassionate use) at this time. We will post the approval via this BTC website and Clinical Trials.Gov when it is open to enrollment.
Breakthrough Therapy Designation opens doors to develop the most efficient clinical trials in collaboration with the FDA, to ultimately obtain approval. At this time, PVSRIPO is not approved for general clinical use.
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 recurrent supratentorial GBM with measurable disease (≥ 1 cm or ≤ 5.5 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 > 5.5 cm diameter in any plane 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.
- Patients may not be on more than 4mg of decadron daily at the start of study.
- Patients may not have steroid myopathy.
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.
Additional information about this clinical trial can be found on clinicaltrials.gov.