Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/9493
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dc.contributor.authorScott, Andrew Men
dc.contributor.authorWiseman, Gregen
dc.contributor.authorWelt, Sydneyen
dc.contributor.authorAdjei, Alexen
dc.contributor.authorLee, Fook-Theanen
dc.contributor.authorHopkins, Wendieen
dc.contributor.authorDivgi, Chaitan Ren
dc.contributor.authorHanson, Lorelei Hen
dc.contributor.authorMitchell, Paul L Ren
dc.contributor.authorGansen, Denise Nen
dc.contributor.authorLarson, Steven Men
dc.contributor.authorIngle, James Nen
dc.contributor.authorHoffman, Eric Wen
dc.contributor.authorTanswell, Paulen
dc.contributor.authorRitter, Gerden
dc.contributor.authorCohen, Leonard Sen
dc.contributor.authorBette, Peteren
dc.contributor.authorArvay, Lisaen
dc.contributor.authorAmelsberg, Andreeen
dc.contributor.authorVlock, Danen
dc.contributor.authorRettig, Wolfgang Jen
dc.contributor.authorOld, Lloyd Jen
dc.date.accessioned2015-05-15T22:36:29Z
dc.date.available2015-05-15T22:36:29Z
dc.date.issued2003-05-01en
dc.identifier.citationClinical Cancer Research; 9(5): 1639-47en
dc.identifier.govdoc12738716en
dc.identifier.otherPUBMEDen
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/9493en
dc.description.abstractThe purpose of this research was to determine the safety, immunogenicity, pharmacokinetics, biodistribution, and tumor uptake of repeat infusions of a complementarity-determining region grafted humanized antibody (sibrotuzumab) directed against human fibroblast activation protein (FAP).A Phase I open-label dose escalation study was conducted in patients with cancers epidemiologically known to be FAP positive. Patients were entered into one of four dosage tiers of 5, 10, 25, or 50 mg/m(2) sibrotuzumab, administered weekly for 12 weeks, with trace labeling with 8-10 mCi of (131)I in weeks 1, 5, and 9.A total of 26 patients were entered into the trial (15 males and 11 females; mean age, 59.9 years; age range, 41-81 years). Twenty patients had colorectal carcinoma, and 6 patients had non-small cell lung cancer. A total of 218 infusions of sibrotuzumab were administered during the first 12 weeks of the study, with 24 patients being evaluable. One patient received an additional 96 infusions on continued-use phase for a total of 108 infusions over a 2-year period, and 1 patient received an additional 6 infusions on continued use. There were no objective tumor responses. Only one episode of dose-limiting toxicity was observed. Therefore, a maximum tolerated dose was not reached. Treatment-related adverse events were observed in 6 patients during the infusional monitoring period. Four of the 6 patients, 3 of whom had associated positive serum human antihuman antibody, were removed from the study because of clinical immune responses. Gamma camera images of [(131)I]sibrotuzumab demonstrated no normal organ uptake of sibrotuzumab, with tumor uptake evident within 24-48 h after infusion. Analysis of pharmacokinetics demonstrated a similar mean terminal t(1/2) of 1.4-2.6 days at the 5, 10, and 25 mg/m(2) dose levels, and with a longer mean t(1/2) of 4.9 days at the 50 mg/m(2) dose level.Repeat infusions of the humanized anti-FAP antibody sibrotuzumab can be administered safely to patients with advanced FAP-positive cancer.en
dc.language.isoenen
dc.subject.otherAdulten
dc.subject.otherAgeden
dc.subject.otherAged, 80 and overen
dc.subject.otherAntibodies, Monoclonal.adverse effects.pharmacokinetics.therapeutic useen
dc.subject.otherAntibodies, Monoclonal, Humanizeden
dc.subject.otherAntigens, Neoplasm.immunology.metabolismen
dc.subject.otherCarcinoma, Non-Small-Cell Lung.blood.drug therapy.secondaryen
dc.subject.otherColorectal Neoplasms.blood.drug therapy.secondaryen
dc.subject.otherDose-Response Relationship, Drugen
dc.subject.otherFemaleen
dc.subject.otherFollow-Up Studiesen
dc.subject.otherGelatinasesen
dc.subject.otherHumansen
dc.subject.otherInfusions, Intravenousen
dc.subject.otherIodine Radioisotopesen
dc.subject.otherLung Neoplasms.blood.drug therapy.secondaryen
dc.subject.otherMaleen
dc.subject.otherMaximum Tolerated Doseen
dc.subject.otherMembrane Proteinsen
dc.subject.otherMiddle Ageden
dc.subject.otherRadioimmunotherapyen
dc.subject.otherSerine Endopeptidases.immunology.metabolismen
dc.subject.otherTreatment Outcomeen
dc.subject.otherTumor Markers, Biological.immunology.metabolismen
dc.titleA Phase I dose-escalation study of sibrotuzumab in patients with advanced or metastatic fibroblast activation protein-positive cancer.en
dc.typeJournal Articleen
dc.identifier.journaltitleClinical Cancer Researchen
dc.identifier.affiliationLudwig Institute for Cancer Research, Melbourne Tumour Biology, Austin, and Repatriation Medical Centre, 3084 Australiaen
dc.description.pages1639-47en
dc.relation.urlhttps://pubmed.ncbi.nlm.nih.gov/12738716en
dc.type.austinJournal Articleen
local.name.researcherMitchell, Paul L R
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptMolecular Imaging and Therapy-
crisitem.author.deptOlivia Newton-John Cancer Research Institute-
crisitem.author.deptMedical Oncology-
crisitem.author.deptOlivia Newton-John Cancer Wellness and Research Centre-
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