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https://ahro.austin.org.au/austinjspui/handle/1/18585
Full metadata record
DC Field | Value | Language |
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dc.contributor.author | Whittle, James R | - |
dc.contributor.author | Lickliter, Jason D | - |
dc.contributor.author | Gan, Hui K | - |
dc.contributor.author | Scott, Andrew M | - |
dc.contributor.author | Simes, John | - |
dc.contributor.author | Solomon, Benjamin J | - |
dc.contributor.author | MacDiarmid, Jennifer A | - |
dc.contributor.author | Brahmbhatt, Himanshu | - |
dc.contributor.author | Rosenthal, Mark A | - |
dc.date | 2015-08-13 | - |
dc.date.accessioned | 2018-08-30T06:23:39Z | - |
dc.date.available | 2018-08-30T06:23:39Z | - |
dc.date.issued | 2015-12 | - |
dc.identifier.citation | Journal of Clinical Neuroscience 2015; 22(12): 1889-94 | - |
dc.identifier.uri | https://ahro.austin.org.au/austinjspui/handle/1/18585 | - |
dc.description.abstract | There 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.iso | eng | - |
dc.subject | Doxorubicin | - |
dc.subject | Epidermal growth factor receptor | - |
dc.subject | First in human | - |
dc.subject | Glioblastoma | - |
dc.subject | Phase I trial | - |
dc.title | First in human nanotechnology doxorubicin delivery system to target epidermal growth factor receptors in recurrent glioblastoma. | - |
dc.type | Journal Article | - |
dc.identifier.journaltitle | Journal of Clinical Neuroscience | - |
dc.identifier.affiliation | Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia | en |
dc.identifier.affiliation | Department of Medical Oncology, Royal Melbourne Hospital, Grattan Street, Parkville, VIC 3050, Australia | - |
dc.identifier.affiliation | Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Heidelberg, Victoria, Australia | en |
dc.identifier.affiliation | Monash Cancer Centre, East Bentleigh, Victoria, Australia | en |
dc.identifier.affiliation | Ludwig Institute for Cancer Research, Austin Hospital, Heidelberg, Victoria, Australia | en |
dc.identifier.affiliation | Royal Prince Alfred Hospital, Camperdown, Sydney, NSW, Australia | en |
dc.identifier.affiliation | EnGeneIC Ltd, Lane Cove West, NSW, Australia | en |
dc.identifier.doi | 10.1016/j.jocn.2015.06.005 | - |
dc.identifier.orcid | 0000-0002-6656-295X | - |
dc.identifier.pubmedid | 26279503 | - |
dc.type.austin | Clinical Trial, Phase I | - |
dc.type.austin | Journal Article | - |
dc.type.austin | Research Support, Non-U.S. Gov't | - |
local.name.researcher | Gan, Hui K | |
item.grantfulltext | none | - |
item.openairetype | Journal Article | - |
item.languageiso639-1 | en | - |
item.fulltext | No Fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.cerifentitytype | Publications | - |
crisitem.author.dept | Medical Oncology | - |
crisitem.author.dept | Olivia Newton-John Cancer Wellness and Research Centre | - |
crisitem.author.dept | Molecular Imaging and Therapy | - |
crisitem.author.dept | Olivia Newton-John Cancer Research Institute | - |
Appears in Collections: | Journal articles |
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