Clinical Trial: Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent
Brief Summary: Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
Detailed Summary:
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.
Sponsor: Oryx GmbH & Co. KG
Current Primary Outcome: Safety and tolerability [ Time Frame: Up to 28 days after the first administration of the IMP ]
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)
Original Primary Outcome: Same as current
Current Secondary Outcome: Efficacy (treatment response) [ Time Frame: Up to 6 months after the first administration of the IMP ]
Parameters for evaluation of efficacy:
- Progression free survival (PFS) based on modified RECIST-criteria depicted as Kaplan-Meier curve
- Overall survival (OS) depicted as Kaplan-Meier curve
Original Secondary Outcome: Same as current
Information By: Oryx GmbH & Co. KG
Dates:
Date Received: February 21, 2011
Date Started: September 2011
Date Completion:
Last Updated: December 3, 2015
Last Verified: March 2015