Phase I study of recombinant human endostatin in patients with advanced solid tumors.
Herbst RS, Hess KR, Tran HT, Tseng JE, Mullani NA, Charnsangavej C, Madden T, Davis DW, McConkey DJ, O’Reilly M, Ellis LM, Pluda J, Hong WK, Abbruzzese JL. Phase I study of recombinant human endostatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2002, 20: 3792-803. PMID: 12228199, DOI: 10.1200/jco.2002.11.061.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAngiogenesis InhibitorsCollagenCollagen Type XVIIIEndostatinsEndothelial Growth FactorsE-SelectinFemaleFibroblast Growth Factor 2Hematologic DiseasesHumansImmunoglobulinsInfusions, IntravenousLymphokinesMagnetic Resonance ImagingMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPeptide FragmentsRecombinant ProteinsTime FactorsTissue DistributionVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsRh-EndoConcentration-time curveRecombinant human endostatinSerum markersPreclinical modelsSolid tumorsHuman endostatinDose-limiting toxic effectAntitumor activityTwo-compartmental open modelAdvanced solid tumorsPhase I trialCentral line accessDose-finding trialMinor antitumor activityI trialIntravenous bolusSerum biomarkersSerum antibodiesPharmacokinetic dispositionAllergic reactionsPatientsPharmacokinetic profileDose levelsPhase IDevelopment of biologic markers of response and assessment of antiangiogenic activity in a clinical trial of human recombinant endostatin.
Herbst RS, Mullani NA, Davis DW, Hess KR, McConkey DJ, Charnsangavej C, O’Reilly M, Kim HW, Baker C, Roach J, Ellis LM, Rashid A, Pluda J, Bucana C, Madden TL, Tran HT, Abbruzzese JL. Development of biologic markers of response and assessment of antiangiogenic activity in a clinical trial of human recombinant endostatin. Journal Of Clinical Oncology 2002, 20: 3804-14. PMID: 12228200, DOI: 10.1200/jco.2002.05.102.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAngiogenesis InhibitorsApoptosisBiomarkersCD3 ComplexCollagenDose-Response Relationship, DrugEndostatinsEndotheliumFemaleFluorodeoxyglucose F18HumansIn Situ Nick-End LabelingLasersMaleMiddle AgedNeoplasmsNeovascularization, PathologicPeptide FragmentsProspective StudiesRecombinant ProteinsTomography, Emission-ComputedConceptsTumor blood flowRh-EndoTumor cell apoptosisPositron emission tomographyBlood flowEndothelial cell apoptosisCell apoptosisClinical trialsAntiangiogenic therapyEndothelial cellsWeeks of therapyStart of therapyDose-finding clinical trialsRecombinant human endostatinHuman recombinant endostatinTreatment of cancerBiologic markersAntiangiogenic treatmentBiopsy specimensAppropriate dosePET scansBiopsy analysisHuman endostatinTherapyTumor tissue