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

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

H-1PV

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Progressive glioblastoma multiforme, Recurrent glioblastoma multiforme, Oncolytic virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Neurosurgery, University Hospital Heidelberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H-1 parvovirus (H-1PV)

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability

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)

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

Full Information

NCT ID

NCT01301430

First Posted

February 21, 2011

Last Updated

November 16, 2022

Sponsor

Oryx GmbH & Co. KG

1. Study Identification

Unique Protocol Identification Number

NCT01301430

Brief Title

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

Acronym

ParvOryx01

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oryx GmbH & Co. KG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

Keywords

Progressive glioblastoma multiforme, Recurrent glioblastoma multiforme, Oncolytic virus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

H-1 parvovirus (H-1PV)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

H-1PV

Other Intervention Name(s)

ParvOryx (brand name of H-1PV)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Safety and tolerability

Description

Time Frame

Up to 28 days after the first administration of the IMP

Secondary Outcome Measure Information:

Title

Efficacy (treatment response)

Description

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

Time Frame

Up to 6 months after the first administration of the IMP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Unterberg, Prof. Dr.

Organizational Affiliation

Department of Neurosurgery, University Hospital Heidelberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bernard Huber, Dr.

Organizational Affiliation

Oryx GmbH & Co. KG

Official's Role

Study Director

Facility Information:

Facility Name

Department of Neurosurgery, University Hospital Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22436661

Citation

Geletneky K, Huesing J, Rommelaere J, Schlehofer JR, Leuchs B, Dahm M, Krebs O, von Knebel Doeberitz M, Huber B, Hajda J. 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: ParvOryx01 protocol. BMC Cancer. 2012 Mar 21;12:99. doi: 10.1186/1471-2407-12-99.

Results Reference

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PubMed Identifier

25730754

Citation

Geletneky K, Leoni AL, Pohlmeyer-Esch G, Loebhard S, Baetz A, Leuchs B, Roscher M, Hoefer C, Jochims K, Dahm M, Huber B, Rommelaere J, Krebs O, Hajda J. Pathology, organ distribution, and immune response after single and repeated intravenous injection of rats with clinical-grade parvovirus H1. Comp Med. 2015 Feb;65(1):23-35.

Results Reference

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PubMed Identifier

25730755

Citation

Geletneky K, Leoni AL, Pohlmeyer-Esch G, Loebhard S, Leuchs B, Hoefer C, Jochims K, Dahm M, Huber B, Rommelaere J, Krebs O, Hajda J. Bioavailability, biodistribution, and CNS toxicity of clinical-grade parvovirus H1 after intravenous and intracerebral injection in rats. Comp Med. 2015 Feb;65(1):36-45.

Results Reference

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PubMed Identifier

28967558

Citation

Geletneky K, Hajda J, Angelova AL, Leuchs B, Capper D, Bartsch AJ, Neumann JO, Schoning T, Husing J, Beelte B, Kiprianova I, Roscher M, Bhat R, von Deimling A, Bruck W, Just A, Frehtman V, Lobhard S, Terletskaia-Ladwig E, Fry J, Jochims K, Daniel V, Krebs O, Dahm M, Huber B, Unterberg A, Rommelaere J. Oncolytic H-1 Parvovirus Shows Safety and Signs of Immunogenic Activity in a First Phase I/IIa Glioblastoma Trial. Mol Ther. 2017 Dec 6;25(12):2620-2634. doi: 10.1016/j.ymthe.2017.08.016. Epub 2017 Aug 24.

Results Reference

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

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