Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme. (ParvOryx01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01301430
First received: February 21, 2011
Last updated: December 3, 2015
Last verified: March 2015

February 21, 2011
December 3, 2015
September 2011
May 2015   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: Up to 28 days after the first administration of the IMP ] [ Designated as safety issue: Yes ]

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)
Same as current
Complete list of historical versions of study NCT01301430 on ClinicalTrials.gov Archive Site
Efficacy (treatment response) [ Time Frame: Up to 6 months after the first administration of the IMP ] [ Designated as safety issue: No ]

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
Same as current
Not Provided
Not Provided
 
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
Drug: H-1PV
H-1PV administered at three increasing doses either intratumorally or intravenously and then 10 days after the first administration intracerebrally (into the walls of tumor resection cavity).
Other Name: ParvOryx (brand name of H-1PV)
Experimental: H-1 parvovirus (H-1PV)
Intervention: Drug: H-1PV

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over or equal to 18 years old,
  • Diagnosis of glioblastoma multiforme,
  • Written informed consent,
  • Recurrent or progressive disease despite previous radio- and/or chemotherapy,
  • Indication for complete or subtotal tumor resection,
  • Life expectancy of at least 3 months,
  • Consent for sampling and investigation of biological specimens,
  • Karnofsky Performance Score over or equal to 60,
  • Adequate seizure control,
  • Adequate bone marrow function: neutrophils > 1.5 x 10exp9/L, platelets > 100 x 10exp9/L, hemoglobin > 9.0 g/dL,
  • Adequate liver function: Bilirubin < 2.0 g/dL, ASAT, ALAT, AP, GGT < 3 x ULN,
  • Adequate renal function: Creatinine < 1.8 g/dL,
  • Adequate blood clotting: aPTT < 35 sec, INR < 1.2,
  • Negative serology for HIV, HBV and HCV,
  • Negative Beta-HCG test in women of childbearing potential,
  • Commitment to use adequate contraception (in both genders) for up to six months after study entry,
  • Commitment to omit exposure to infants < 18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.

Exclusion Criteria:

  • Multifocal disease,
  • Evidence of distant tumor metastases,
  • Contraindications for MRI,
  • Active infection within 5 days prior to the study inclusion,
  • Chemotherapy within 4 weeks prior to the study inclusion,
  • Radiotherapy within 6 weeks prior to the study inclusion,
  • Participation in another interventional trial within the last 30 days,
  • Treatment with antiangiogenic substances within 21 days prior to therapy.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01301430
ParvOryx01
Yes
Not Provided
Not Provided
Oryx GmbH & Co. KG
Oryx GmbH & Co. KG
Not Provided
Principal Investigator: Andreas Unterberg, Prof. Dr. Department of Neurosurgery, University Hospital Heidelberg
Study Director: Bernard Huber, Dr. Oryx GmbH & Co. KG
Oryx GmbH & Co. KG
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP