Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas

This is an interventional treatment trial for Malignant Glioma focused on measuring Oncolytics Biotech, cancer alternative therapies, malignant glioma, glioblastoma multiforme, oncolytic virus, reovirus, REOLYSIN Read More

Abbreviated Inclusion Criteria:

• PHASE I: 1st, 2nd or 3rd recurrence of: glioblastoma multiforme; gliosarcoma; anaplastic astrocytoma; anaplastic mixed glioma; or anaplastic oligodendroglioma
• PHASE II: 1st recurrence of glioblastoma multiforme (only)
• Progressing/recurrent lesion which is ≥1cmx1cm. For the Phase II study the lesion must be ≤5cmx5cm, defined by MRI only
• Be fully recovered from any prior therapy
• Have been treated at the time of original diagnosis by surgery and external beam radiation to a dose of at least 5000 cGy; radiotherapy completed at least 6 weeks before REOLYSIN® therapy
• Any intracranial surgery, except for stereotactic needle biopsy, must have occurred at least 4 weeks before REOLYSIN® therapy
• Any anti-cancer drug therapy must have been completed at least 4 weeks (6 weeks in the case of prior nitrosourea therapy) before REOLYSIN® therapy
• Have a life expectancy of ≥8 weeks and a Karnofsky Performance Status (KPS) of ≥60
• Absolute neutrophils ≥1.5 x10^9/L; hemoglobin ≥100g/L; platelets ≥100 x 10^9/L
• ALT ≥1.5 x ULN; total bilirubin ≥1.5 x ULN
• Serum creatinine ≤1.5 x ULN
• EKG with no evidence of active, acute cardiovascular disease
• PT within normal limit
• Women of childbearing potential must have a negative pregnancy test
• Reside or have suitable living arrangements within a reasonable geographical area of the study site and be able to participate in all follow-up visits
• Patients requiring corticosteroids must be on a stable dose of steroid for at least two weeks prior to baseline MRI and when entered in the study. Maximum daily dose of 24 mg/day of dexamethasone/decadron or equivalent

Abbreviated Exclusion Criteria:

• Patients who are sexually active and not willing to use barrier methods of contraception; women who are breastfeeding
• Patients with unstable or serious concurrent medical or psychiatric conditions that would interfere with study treatment or follow-up
• Patients with more than one discrete enhancing lesion on MRI, or radiographic evidence of satellite lesions or leptomeningeal disease not obviously contiguous by FLAIR imaging
• Patients who may require further neurosurgery within 4 weeks after REOLYSIN® treatment
• Patients with a prior history of encephalitis, multiple sclerosis or other significant chronic CNS disease
• Patients who have evidence of a current CNS infection, meningeal gliomatosis or gliomatosis cerebri
• Patients with tumor that to be treated would require needle or catheter passage through a ventricle, the posterior fossa or basal ganglia; or patients with tumors invading the ventricle
• Patients who have previously participated in experimental viral therapy protocols
• Patients who have had prior intratumoral gene therapy or other intratumoral therapies
• Patients who have had Gliadel wafer therapy less than 6 months prior to enrollment
• Patients who have a history of bleeding disorders including congenital or acquired coagulopathies
• Patients who have a known history of hepatitis or tuberculosis
• Patients who have a known history of hereditary or acquired immunodeficiency including HIV infection
• Patients who have impaired non-neurological organ function (>Grade 1)
• Patients who have used systemic antiviral (or potentially antiviral) therapies within 28 days of enrollment
• Patients who have had brachytherapy or radiosurgery to the brain at any time
• Patients with previous or concurrent malignancies at other sites (except surgically-cured carcinoma in situ of the cervix and non-melanoma skin cancer)
• Prior or current medical history indicating that a patient may be significantly immunosuppressed