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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01301430
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Oryx GmbH & Co. KG

Tracking Information
First Submitted Date  ICMJE February 21, 2011
First Posted Date  ICMJE February 23, 2011
Last Update Posted Date December 4, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2011)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2011)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: H-1 parvovirus (H-1PV)
Intervention: Drug: H-1PV
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2013)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2011)
19
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01301430
Other Study ID Numbers  ICMJE ParvOryx01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Oryx GmbH & Co. KG
Original Responsible Party Dr. Karsten Geletneky (principal investigator), Department of Neurosurgery, University Hospital Heidelberg
Current Study Sponsor  ICMJE Oryx GmbH & Co. KG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Unterberg, Prof. Dr. Department of Neurosurgery, University Hospital Heidelberg
Study Director: Bernard Huber, Dr. Oryx GmbH & Co. KG
PRS Account Oryx GmbH & Co. KG
Verification Date March 2015

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