Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/18585
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dc.contributor.authorWhittle, James R-
dc.contributor.authorLickliter, Jason D-
dc.contributor.authorGan, Hui K-
dc.contributor.authorScott, Andrew M-
dc.contributor.authorSimes, John-
dc.contributor.authorSolomon, Benjamin J-
dc.contributor.authorMacDiarmid, Jennifer A-
dc.contributor.authorBrahmbhatt, Himanshu-
dc.contributor.authorRosenthal, Mark A-
dc.date2015-08-13-
dc.date.accessioned2018-08-30T06:23:39Z-
dc.date.available2018-08-30T06:23:39Z-
dc.date.issued2015-12-
dc.identifier.citationJournal of Clinical Neuroscience 2015; 22(12): 1889-94-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/18585-
dc.description.abstractThere are limited treatment options for patients with recurrent glioblastoma (GBM). The EnGeneIC delivery vehicle (EDV) is a novel nanocellular (minicell) compound which packages theoretically effective concentrations of chemotherapeutic drugs that are designed to target tumors via minicell-surface attached bispecific proteins (EnGeneIC, Lane Cove West, NSW, Australia). Epidermal growth factor receptor (EGFR) is overexpressed in 40-50% of patients with GBM and is a promising target for new therapeutics. (V)EDVDox contains doxorubicin (Dox) within the minicells and targets EGFR through Vectibix (V; Amgen Biologicals, Thousand Oaks, CA, USA). We conducted a first in human Phase I study of (V)EDVDox in adults with recurrent GBM expressing EGFR on immunohistochemistry, following standard therapy including radiation and temozolomide, to establish a safe maximum tolerated dose and determine a recommended Phase II dose (RPTD). (V)EDVDox was administered weekly in an 8week cycle, with dose escalation in successive cohorts of patients using a standard 3+3 design. In total, 14 patients were treated at three dose levels, and the RPTD was identified as 5×10(9)(V)EDVDox. Overall (V)EDVDox was well tolerated, with no dose limiting toxicity and no withdrawals from the study due to adverse events. The most common adverse events were nausea, fever, and chills or rigors, experienced in seven, five and five patients, respectively. Transient uncomplicated hypophosphatemia was seen in seven patients and was not dose-related. Our results demonstrate that (V)EDVDox, up to a dose of 5×10(9)(V)EDVDox weekly, is well tolerated in patients with recurrent GBM.-
dc.language.isoeng-
dc.subjectDoxorubicin-
dc.subjectEpidermal growth factor receptor-
dc.subjectFirst in human-
dc.subjectGlioblastoma-
dc.subjectPhase I trial-
dc.titleFirst in human nanotechnology doxorubicin delivery system to target epidermal growth factor receptors in recurrent glioblastoma.-
dc.typeJournal Article-
dc.identifier.journaltitleJournal of Clinical Neuroscience-
dc.identifier.affiliationPeter MacCallum Cancer Centre, East Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Medical Oncology, Royal Melbourne Hospital, Grattan Street, Parkville, VIC 3050, Australia-
dc.identifier.affiliationOlivia Newton-John Cancer Wellness and Research Centre, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationMonash Cancer Centre, East Bentleigh, Victoria, Australiaen
dc.identifier.affiliationLudwig Institute for Cancer Research, Austin Hospital, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationRoyal Prince Alfred Hospital, Camperdown, Sydney, NSW, Australiaen
dc.identifier.affiliationEnGeneIC Ltd, Lane Cove West, NSW, Australiaen
dc.identifier.doi10.1016/j.jocn.2015.06.005-
dc.identifier.orcid0000-0002-6656-295X-
dc.identifier.pubmedid26279503-
dc.type.austinClinical Trial, Phase I-
dc.type.austinJournal Article-
dc.type.austinResearch Support, Non-U.S. Gov't-
local.name.researcherGan, Hui K
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptMedical Oncology-
crisitem.author.deptOlivia Newton-John Cancer Wellness and Research Centre-
crisitem.author.deptMolecular Imaging and Therapy-
crisitem.author.deptOlivia Newton-John Cancer Research Institute-
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