Evidence map›Paper›PMID 28967558›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2017

Oncolytic H-1 Parvovirus Shows Safety and Signs of Immunogenic Activity in a First Phase I/IIa Glioblastoma Trial.

Karsten Geletneky, Jacek Hajda, Assia L Angelova, Barbara Leuchs, David Capper, Andreas J Bartsch, Jan-Oliver Neumann, Tilman Schöning, Johannes Hüsing, Birgit Beelte and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01301430 (Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1), which is not on this map. Cited by 167 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
167citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01301430 phase1 / phase2completednot on this map

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.

TypeinterventionalSponsorOryx GmbH & Co. KGRan2011 to 2015Enrolled18ConditionsGlioblastoma MultiformeArmsH-1PV
3 · Its place in the literature

Who cites it

167 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. A systematic review of immunotherapy in high-grade glioma: learning from the past to shape future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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  7. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
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107 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Karsten GeletnekyDepartment of Neurosurgery, University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
Jacek HajdaCoordination Centre for Clinical Trials, University Hospital, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.
Assia L AngelovaDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
Barbara LeuchsDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
David CapperDepartment of Neuropathology, University Hospital, Im Neuenheimer Feld 220, 69120 Heidelberg, Germany; Clinical Cooperation Unit Neuropathology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.
Andreas J BartschDepartment of Neuroradiology, University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
Jan-Oliver NeumannDepartment of Neurosurgery, University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
Tilman SchöningUniversity Hospital Pharmacy, Im Neuenheimer Feld 670, 69120 Heidelberg, Germany.
Johannes HüsingCoordination Centre for Clinical Trials, University Hospital, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.
Birgit BeelteCoordination Centre for Clinical Trials, University Hospital, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany.
Irina KiprianovaDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
Mandy RoscherDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
Rauf BhatDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
Andreas von DeimlingDepartment of Neuropathology, University Hospital, Im Neuenheimer Feld 220, 69120 Heidelberg, Germany; Clinical Cooperation Unit Neuropathology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.
Wolfgang BrückDepartment of Neuropathology, University Medical Center, Georg August University, 37099 Göttingen, Germany.
Alexandra JustDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
Veronika FrehtmanDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
Stephanie LöbhardEurofins BioPharma Product Testing, Behringstraße 6/8, 82152 Planegg, Germany.
Elena Terletskaia-LadwigLaboratory Prof. Dr. Gisela Enders & Colleagues, MVZ and Institute of Virology, Infectious Diseases and Epidemiology e.V., Stuttgart, Germany.
Jeremy FryProImmune, The Magdalen Centre, Oxford Science Park, Oxford OX4 4GA, UK.
Karin JochimsIASON Consulting, Mühlenstraße 26A, 52382 Niederzier, Germany.
Volker DanielDepartment of Transplantation Immunology, Institute of Immunology, University Hospital, Im Neuenheimer Feld 305, 69120 Heidelberg, Germany.
Ottheinz KrebsOryx GmbH & Co. KG, Marktplatz 1, 85598 Baldham, Germany.
Michael DahmOryx GmbH & Co. KG, Marktplatz 1, 85598 Baldham, Germany.
Bernard HuberOryx GmbH & Co. KG, Marktplatz 1, 85598 Baldham, Germany.
Andreas UnterbergDepartment of Neurosurgery, University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
Jean RommelaereDepartment of Tumor Virology, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, 69120 Heidelberg, Germany. Electronic address: j.rommelaere@dkfz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oncolytic virotherapy may be a means of improving the dismal prognosis of malignant brain tumors. The rat H-1 parvovirus (H-1PV) suppresses tumors in preclinical glioma models, through both direct oncolysis and stimulation of anticancer immune responses. This was the basis of ParvOryx01, the first phase I/IIa clinical trial of an oncolytic parvovirus in recurrent glioblastoma patients. H-1PV (escalating dose) was administered via intratumoral or intravenous injection. Tumors were resected 9 days after treatment, and virus was re-administered around the resection cavity. Primary endpoints were safety and tolerability, virus distribution, and maximum tolerated dose (MTD). Progression-free and overall survival and levels of viral and immunological markers in the tumor and peripheral blood were also investigated. H-1PV treatment was safe and well tolerated, and no MTD was reached. The virus could cross the blood-brain/tumor barrier and spread widely through the tumor. It showed favorable pharmacokinetics, induced antibody formation in a dose-dependent manner, and triggered specific T cell responses. Markers of virus replication, microglia/macrophage activation, and cytotoxic T cell infiltration were detected in infected tumors, suggesting that H-1PV may trigger an immunogenic stimulus. Median survival was extended in comparison with recent meta-analyses. Altogether, ParvOryx01 results provide an impetus for further H-1PV clinical development.

Indexed as

Genetic TherapyOncolytic VirotherapyAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleGene ExpressionGenetic VectorsGlioblastomaH-1 parvovirusHumansLymphocytes, Tumor-InfiltratingMaleMiddle AgedMolecular Targeted TherapyOncolytic VirusesRadiotherapyclinical trialglioblastomaoncolytic parvovirustumor microenvironment

Identifiers

PMID28967558
PMCPMC5768665

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.