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Pancreatic Neoplasms: HELP
Articles by Christine E. Engeland
Based on 1 article published since 2010
(Why 1 article?)
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Between 2010 and 2020, Christine E. Engeland wrote the following article about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Clinical Trial A non-controlled, single arm, open label, phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer: ParvOryx02 protocol. 2017

Hajda, Jacek / Lehmann, Monika / Krebs, Ottheinz / Kieser, Meinhard / Geletneky, Karsten / Jäger, Dirk / Dahm, Michael / Huber, Bernard / Schöning, Tilman / Sedlaczek, Oliver / Stenzinger, Albrecht / Halama, Niels / Daniel, Volker / Leuchs, Barbara / Angelova, Assia / Rommelaere, Jean / Engeland, Christine E / Springfeld, Christoph / Ungerechts, Guy. ·Coordination Centre for Clinical Trials, University Hospital Heidelberg, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany. Jacek.Hajda@med.uni-heidelberg.de. · Coordination Centre for Clinical Trials, University Hospital Heidelberg, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany. · Oryx GmbH & Co KG, Marktplatz 1, 85598, Baldham, Germany. · Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Marsilius-Arkaden, Tower West, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany. · Department of Neurosurgery, Klinikum Darmstadt, Grafenstraße 9, 64283, Darmstadt, Germany. · Department of Medical Oncology, National Center for Tumor Diseases (NCT), Im Neuenheimer Feld 460, 69120, Heidelberg, Germany. · Central Pharmacy, University Hospital Heidelberg, Im Neuenheimer Feld 670, 69120, Heidelberg, Germany. · Department of Radiology, German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany. · Department of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 69120, Heidelberg, Germany. · Tissue Imaging & Analysis Center (TIGA), University Heidelberg - BioQuant, Im Neuenheimer Feld 267, 69120, Heidelberg, Germany. · Institute of Immunology, Transplantation Immunology, University Hospital Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany. · Department of Applied Tumor Virology, German Cancer Research Center, Im Neuenheimer Feld 242, 69120, Heidelberg, Germany. ·BMC Cancer · Pubmed #28851316.

ABSTRACT: BACKGROUND: Metastatic pancreatic cancer has a dismal prognosis, with a mean six-month progression-free survival of approximately 50% and a median survival of about 11 months. Despite intensive research, only slight improvements of clinical outcome could be achieved over the last decades. Hence, new and innovative therapeutic strategies are urgently required. ParvOryx is a drug product containing native parvovirus H-1 (H-1PV). Since H-1PV was shown to exert pronounced anti-neoplastic effects in pre-clinical models of pancreatic cancer, the drug appears to be a promising candidate for treatment of this malignancy. METHODS: ParvOryx02 is a non-controlled, single arm, open label, dose-escalating, single center trial. In total seven patients with pancreatic cancer showing at least one hepatic metastasis are to be treated with escalating doses of ParvOryx according to the following schedule: i) 40% of the total dose infused intravenously in equal fractions on four consecutive days, ii) 60% of the total dose injected on a single occasion directly into the hepatic metastasis at varying intervals after intravenous infusions. The main eligibility criteria are: age ≥ 18 years, disease progression despite first-line chemotherapy, and at least one hepatic metastasis. Since it is the second trial within the drug development program, the study primarily explores safety and tolerability after further dose escalation of ParvOryx. The secondary objectives are related to the evaluation of certain aspects of anti-tumor activity and clinical efficacy of the drug. DISCUSSION: This trial strongly contributes to the clinical development program of ParvOryx. The individual hazards for patients included in the current study and the environmental risks are addressed and counteracted adequately. Besides information on safety and tolerability of the treatment after further dose escalation, thorough evaluations of pharmacokinetics and intratumoral spread as well as proof-of-concept (PoC) in pancreatic cancer will be gained in the course of the trial. TRIAL REGISTRATION: ClinicalTrials.gov-ID: NCT02653313 , Registration date: Dec. 4th, 2015.