Clinical Trial Details
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NCT03043391 : Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
PhasePhase 1
AgesMin: 12 Years Max: 18 Years
Inclusion Criteria:

- Patients must have a recurrent supratentorial WHO Grade III malignant glioma
(anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma,
anaplastic pleomorphic xanthoastrocytoma, ependymoma) or WHO Grade IV malignant glioma
(glioblastoma, gliosarcoma) based on imaging studies with measurable disease (= 1 cm
and = 5.5 cm of contrast-enhancing tumor). The prior histopathology must be consistent
with a World Health Organization (WHO) Grade III or IV malignant glioma confirmed by
the study pathologist, Roger McLendon, or his designee. There is no standard of care
treatment for children with Grade III/IV gliomas. Patients must have completed
first-line treatments including surgical procedure and a minimum of 54 Gray of
radiation prior to participating in this trial.

- Due to the potential implications of the treatment on the developing CNS, all patients
must be = 12 years of age and = 18 years of age at the time of entry into the study.

- The patient must have a Lansky or Karnofsky Performance Score (KPS) of = 70% at the
time of entry.

- Laboratory Studies:

- Platelet count = 125,000 per microliter prior to biopsy. Platelets = 100,000 per
microliter prior to infusion;

- Prothrombin and Partial Thromboplastin Times = 1.2 x upper limit of normal (ULN) prior
to biopsy;

- Positive serum anti-poliovirus titer = 1:8 prior to biopsy;

- Creatinine = 1.2 x ULN prior to biopsy;

- Total bilirubin, AST, ALT, alkaline phosphatase = 2.5 x ULN prior to biopsy;

- Neutrophil count = 1000 per microliter prior to biopsy;

- Hemoglobin = 9 gm/dl prior to biopsy (can be transfused).

- The patient must have received a boost immunization with trivalent inactivated IPOLâ„¢
(Sanofi-Pasteur) = 1 week prior to administration of the study agent.

- At the time of biopsy, prior to administration of virus, the presence of recurrent
tumor must be confirmed by histopathological analysis.

- A signed informed consent form approved by the Duke University Institutional Review
Board (IRB) will be required for patient enrollment into the study. Patients (if 18
years old) or their parent(s) or guardian(s) must be able to read and understand the
informed consent document and must sign the informed consent indicating that they are
aware of the investigational nature of this study. All children will have to provide
assent to the study.

- Able to undergo brain MRI with and without contrast without requiring general

Exclusion Criteria:

- Pregnant or breast-feeding. Female patients of child-bearing potential or female
sexual partners (who are of child-bearing potential) of male patients must use at
least one of the following methods of medically acceptable contraceptives: approved
hormonal contraceptives (such as birth control pills, patches, implants or infusions),
an intrauterine device (IUD), or a barrier method of contraception (such as a condom
or diaphragm) used ith spermicide. Because all patients are required to have a boost
immunization of trivalent inactivated IPOLâ„¢, there should be no risk of transmission
of a mother to her fetus after receiving intracranial PVSRIPO. As such, patients who
become pregnant after receiving PVSRIPO will continue to be monitored in the same
manner, i.e. per protocol, unless the assessment is contra-indicated during pregnancy.
Partners who become pregnant will sign a Pregnant Partner Information Form and
information regarding the pregnancy and its outcome may be collected.

- Patients with an impending, life-threatening cerebral herniation syndrome, based on
the assessment of the study neurosurgeon.

- Patients with an active infection requiring intravenous treatment or having an
unexplained febrile illness (Tmax > 99.5°F).

- Patients with known immunosuppressive disease or known human immunodeficiency virus

- Patients with unstable or severe intercurrent medical conditions such as severe heart
(New York Heart Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled
diabetes mellitus.

- Patients with albumin allergy.

- Gadolinium allergy.

- A history of neurological complications due to past PV infection would imply previous
virus replication in the CNS. Based on animal studies, previous exposure to poliovirus
administered intracerebrally can reduce subsequent virus replication in the CNS.

- Patients who have not recovered from the toxic effects of prior chemo- and/or
radiation therapy. Guidelines for this recovery period are dependent upon the specific
therapeutic agent being used:

- Patients who are less than 12 weeks from radiation therapy, unless progressive disease
outside of the radiation field or 2 consecutive scans with disease progression or
histopathologic confirmation of recurrent tumor.

- Patients who have received chemotherapy or bevacizumab = 4 weeks [except for
nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or
cyclophosphamide (1 week)] prior to starting the study drug unless patients have
recovered from side effects of such therapy.

- Patients who have received immunotherapy = 4 weeks prior to starting the study drug
unless patients have recovered from side effects of such therapy.

- Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord, tumors
extending into or crossing the corpus callosum, intraventricular tumors, pineal
tumors, pituitary tumors, radiological evidence of active (growing) multifocal
disease, leptomeningeal disease, or other locations at the discretion of the treating

- Patients with a diagnosis of agammaglobulinemia, that is:

- Undetectable anti-tetanus toxoid IgG

- Known history of agammaglobulinemia

- Patients who are on dexamethasone receiving > 4 mg/day in the two weeks prior to
admission for intra-cerebral delivery of PVSRIPO.

- Patients with worsening steroid myopathy (history of gradual progression of bilateral
proximal muscle weakness, and atrophy of proximal muscle groups).

- Patients with prior, unrelated malignancy requiring current active treatment with the
exception of cervical carcinoma in situ and adequately treated basal cell or squamous
cell carcinoma of the skin.
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