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| Verfasst von: | Hajda, Jacek [VerfasserIn]  |
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| | Leuchs, Barbara [VerfasserIn] |
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| | Angelova, Assia L. [VerfasserIn] |
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| | Frehtman, Veronika [VerfasserIn] |
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| | Rommelaere, Jean [VerfasserIn] |
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| | Mertens, Mieke [VerfasserIn] |
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| | Pilz, Maximilian [VerfasserIn] |
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| | Kieser, Meinhard [VerfasserIn] |
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| | Krebs, Ottheinz [VerfasserIn] |
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| | Dahm, Michael [VerfasserIn] |
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| | Huber, Bernard [VerfasserIn] |
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| | Engeland, Christine Elisabeth [VerfasserIn] |
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| | Mavratzas, Athanasios [VerfasserIn] |
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| | Hohmann, Nicolas [VerfasserIn] |
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| | Schreiber, Jutta Sylvina [VerfasserIn] |
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| | Jäger, Dirk [VerfasserIn] |
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| | Halama, Niels [VerfasserIn] |
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| | Sedlaczek, Oliver [VerfasserIn] |
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| | Gaida, Matthias [VerfasserIn] |
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| | Daniel, Volker [VerfasserIn] |
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| | Springfeld, Christoph [VerfasserIn] |
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| | Ungerechts, Guy [VerfasserIn] |
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| Titel: | Phase 2 trial of oncolytic H-1 parvovirus therapy shows safety and signs of immune system activation in patients with metastatic pancreatic ductal adenocarcinoma |
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| Verf.angabe: | Jacek Hajda, Barbara Leuchs, Assia L. Angelova, Veronika Frehtman, Jean Rommelaere, Mieke Mertens, Maximilian Pilz, Meinhard Kieser, Ottheinz Krebs, Michael Dahm, Bernard Huber, Christine E. Engeland, Athanasios Mavratzas, Nicolas Hohmann, Jutta Schreiber, Dirk Jäger, Niels Halama, Oliver Sedlaczek, Matthias M. Gaida, Volker Daniel, Christoph Springfeld, and Guy Ungerechts |
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| E-Jahr: | 2021 |
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| Jahr: | August 23, 2021 |
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| Umfang: | 11 S. |
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| Fussnoten: | Gesehen am 30.12.2021 |
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| Titel Quelle: | Enthalten in: Clinical cancer research |
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| Ort Quelle: | Philadelphia, Pa. [u.a.] : AACR, 1995 |
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| Jahr Quelle: | 2021 |
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| Band/Heft Quelle: | 27(2021), 20, Seite 5546-5556 |
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| ISSN Quelle: | 1557-3265 |
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| Abstract: | Purpose: To investigate the safety, clinical efficacy, virus pharmacokinetics, shedding, and immune response after administration of an oncolytic parvovirus (H-1PV, ParvOryx) to patients with metastatic pancreatic ductal adenocarcinoma (PDAC) refractory to first-line therapy. - Patients and Methods: This is a noncontrolled, single-arm, open-label, dose-escalating, single-center clinical trial. Seven patients with PDAC and at least one liver metastasis were included. ParvOryx was administered intravenously on 4 consecutive days and as an intralesional injection, 6 to 13 days thereafter. Altogether, three escalating dose levels were investigated. In addition, gemcitabine treatment was initiated on day 28. - Results: ParvOryx showed excellent tolerability with no dose-limiting toxicities. One patient had a confirmed partial response and one patient revealed an unconfirmed partial response according to RECIST criteria. Both patients showed remarkably long surivial of 326 and 555 days, respectively. Investigation of pharmacokinetics and virus shedding revealed dose dependency with no excretion of active virus particles in saliva or urine and very limited excretion in feces. H-1PV nucleic acids were detected in tumor samples of four patients. All patients showed T-cell responses to viral proteins. An interesting immunologic pattern developed in tumor tissues and in blood of both patients with partial response suggesting immune activation after administration of ParvOryx. - Conclusions: The trial met all primary objectives, revealed no environmental risks, and indicated favorable immune modulation after administration of ParvOryx. It can be considered a good basis for further systematic clinical development alone or in combination with immunomodulatory compounds. |
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| DOI: | doi:10.1158/1078-0432.CCR-21-1020 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext: https://doi.org/10.1158/1078-0432.CCR-21-1020 |
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| | Volltext: https://clincancerres.aacrjournals.org/content/27/20/5546 |
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| | DOI: https://doi.org/10.1158/1078-0432.CCR-21-1020 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| K10plus-PPN: | 1784430978 |
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| Verknüpfungen: | → Zeitschrift |
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Phase 2 trial of oncolytic H-1 parvovirus therapy shows safety and signs of immune system activation in patients with metastatic pancreatic ductal adenocarcinoma / Hajda, Jacek [VerfasserIn]; August 23, 2021 (Online-Ressource)
