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

November 16, 2022 updated by: Oryx GmbH & Co. KG

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Department of Neurosurgery, University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ParvOryx (brand name of H-1PV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 28 days after the first administration of the IMP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 months after the first administration of the IMP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ParvOryx01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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