Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects
suffering from glioblastoma multiforme.
H-1PV will primarily be administered either intratumoral or intravenously. Ten days
thereafter a complete or a subtotal tumor resection with a subsequent administration of
H-1PV into the walls of the resection cavity will be carried out.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
Parameters for assessment of safety and tolerability: physical/neurological examinations (pathological findings as quality and quantity) adverse events (quality and quantity per dose level) vital signs, ECG, laboratory parameters (pathological findings as quality and quantity, for laboratory parameters: descriptive statistics) viral shedding and viral specific antibodies (quantity depicted over time)
Up to 28 days after the first administration of the IMP
Andreas Unterberg, Prof. Dr.
Department of Neurosurgery, University Hospital Heidelberg