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History of Changes for Study: NCT01301430
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme. (ParvOryx01)
Latest version (submitted December 3, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 22, 2011 None (earliest Version on record)
2 April 19, 2011 Study Status and Contacts/Locations
3 September 27, 2011 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Oversight
4 November 19, 2013 Study Status and Study Design
5 March 26, 2015 Recruitment Status, Study Status, Contacts/Locations and References
6 May 27, 2015 Recruitment Status, Study Status and Study Design
7 December 3, 2015 Study Design and Study Status
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Study NCT01301430
Submitted Date:  February 22, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: ParvOryx01
Brief Title: Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme. (ParvOryx01)
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 Glioblastoma Multiforme.
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2011
Overall Status: Not yet recruiting
Study Start: May 2011
Primary Completion: December 2012 [Anticipated]
Study Completion: May 2013 [Anticipated]
First Submitted: February 21, 2011
First Submitted that
Met QC Criteria:
February 22, 2011
First Posted: February 23, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 22, 2011
Last Update Posted: February 23, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Oryx GmbH & Co. KG
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
Detailed Description:

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.

Open or close this module Conditions
Conditions: Glioblastoma Multiforme
Keywords: Progressive glioblastoma multiforme
Recurrent glioblastoma multiforme
Oncolytic virus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 19 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: H-1 parvovirus (H-1PV) 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 Names:
  • ParvOryx (brand name of H-1PV)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Karsten Geletneky, Dr.
Telephone: +49 06221/5639 Ext. 672
Email: Karsten.Geletneky@med.uni-heidelberg.de
Central Contact Backup: Jacek Hajda, Dr.
Telephone: +49 06221/5634 Ext. 507
Email: Jacek.Hajda@med.uni-heidelberg.de
Study Officials: Karsten Geletneky, Dr
Principal Investigator
Department of Neurosurgery, University Hospital Heidelberg
Bernard Huber, Dr.
Study Director
Oryx GmbH & Co. KG
Locations: Germany
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, Germany, 69120
Contact:Contact: Karsten Geletneky, Dr. +49 06221/56 39 Ext. 672 karsten.Geletneky@med.uni-heidelberg.de
Contact:Principal Investigator: Karsten Geletneky, Dr.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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