MC-1472 is an open-label Phase I trial to clarify the safety, and determine possible efficacy, of GM-CSF given prior to administration of intravenous REOLYSIN® for children with malignant high grade brain tumours. GM-CSF will be administered on days one and two of each twenty-eight day cycle, with REOLYSIN® administered on days three, four and five. Treatment will be given for up to 12 cycles if patients remain without evidence of tumour progression and without intolerable toxicity. The primary objective for the nine to 18 patients of the Phase 1 study is safety and tolerability. Secondary objectives include median progression-free and overall survival in this patient population.
Eligible patients include those between the ages of 10 and 21 with histologically confirmed high grade (grade 3 or 4) primary brain tumour either classified as a glioma (including astrocytoma, anaplastic oligodendroglioma and glioblastoma multiforme), medulloblastoma, atypical teratoid/rhabdoid tumour or primitive neuroectodermal tumour. Patients must have no known curative therapy available and can have had up to two chemotherapy regimens for the brain tumour previously.
The study is being sponsored and conducted by the Mayo Clinic based in Rochester, Minnesota.