We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301430
First Posted: February 23, 2011
Last Update Posted: December 4, 2015
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.
Information provided by (Responsible Party):
Oryx GmbH & Co. KG
  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: 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.

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 ]

    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 ]

    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


Enrollment: 18
Study Start Date: September 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Germany
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, Germany, 69120
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

Publications:
Responsible Party: Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01301430     History of Changes
Other Study ID Numbers: ParvOryx01
First Submitted: February 21, 2011
First Posted: February 23, 2011
Last Update Posted: December 4, 2015
Last Verified: March 2015

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

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