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

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ClinicalTrials.gov Identifier: NCT01301430
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
Oryx GmbH & Co. KG

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

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: H-1PV Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : September 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301430


Locations
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Germany
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Oryx GmbH & Co. KG
Investigators
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Principal Investigator: Andreas Unterberg, Prof. Dr. Department of Neurosurgery, University Hospital Heidelberg
Study Director: Bernard Huber, Dr. Oryx GmbH & Co. KG
More Information
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Publications:

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Responsible Party: Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01301430    
Other Study ID Numbers: ParvOryx01
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: March 2015
Keywords provided by Oryx GmbH & Co. KG:
Progressive glioblastoma multiforme
Recurrent glioblastoma multiforme
Oncolytic virus
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue