Clinical Trials for Adults | Dose-Finding and Safety Study of an Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Glioblastoma
Since this is a first in human agent and clinical trial, pediatric patients cannot be treated at this time.
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 by clicking here.