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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oryx GmbH & Co. KG
Sponsor:
Information provided by (Responsible Party):
Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01301430
First received: February 21, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: H-1PV
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Oryx GmbH & Co. KG:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 18
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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 Name: ParvOryx (brand name of H-1PV)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301430

Contacts
Contact: Karsten Geletneky, Dr. +49 06221/5639 ext 672 Karsten.Geletneky@med.uni-heidelberg.de
Contact: Jacek Hajda, Dr. +49 06221/5634 ext 507 Jacek.Hajda@med.uni-heidelberg.de

Locations
Germany
Department of Neurosurgery, University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Karsten Geletneky, Dr.    +49 06221/56 39 ext 672    karsten.Geletneky@med.uni-heidelberg.de   
Principal Investigator: Karsten Geletneky, Dr.         
Sponsors and Collaborators
Oryx GmbH & Co. KG
Investigators
Principal Investigator: Andreas Unterberg, Prof. Dr. Department of Neurosurgery, University Hospital Heidelberg
Study Director: Bernard Huber, Dr. Oryx GmbH & Co. KG
  More Information

No publications provided by Oryx GmbH & Co. KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01301430     History of Changes
Other Study ID Numbers: ParvOryx01
Study First Received: February 21, 2011
Last Updated: November 19, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Oryx GmbH & Co. KG:
Progressive glioblastoma multiforme
Recurrent glioblastoma multiforme
Oncolytic virus

Additional relevant MeSH terms:
Glioblastoma
Parvoviridae Infections
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 31, 2014