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

NCT01301430 | Completed Phase 1 DMC

• 1 other identifier: ParvOryx01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioblastoma Multiforme

Keywords

Progressive glioblastoma multiforme; Recurrent glioblastoma multiforme; Oncolytic virus

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 28 days after the first administration of the IMP

Secondary Outcomes (1)

• Efficacy (treatment response)

  Up to 6 months after the first administration of the IMP

Study Arms (1)

H-1 parvovirus (H-1PV)

EXPERIMENTAL

Drug: H-1PV

Interventions

H-1PV DRUG

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).

Also known as: ParvOryx (brand name of H-1PV)

H-1 parvovirus (H-1PV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Multifocal disease,
• Evidence of distant tumor metastases,
• Contraindications for MRI,
• Participation in another interventional trial within the last 30 days,
• Treatment with antiangiogenic substances within 21 days prior to therapy.

Sponsors & Collaborators

• Oryx GmbH & Co. KG: lead

Study Sites (1)

Department of Neurosurgery, University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (4)

• 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.

  PMID: 22436661 BACKGROUND

• 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.

  PMID: 25730754 BACKGROUND

• 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.

  PMID: 25730755 BACKGROUND

• 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.

  PMID: 28967558 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Andreas Unterberg, Prof. Dr.

  Department of Neurosurgery, University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Bernard Huber, Dr.

  Oryx GmbH & Co. KG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: February 23, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 21, 2022

Record last verified: 2015-03

Locations

DE (1)