2023
Trial in Progress: An Open-Label Expansion Trial Evaluating the Safety, PK/PD, and Clinical Activity of Emavusertib (CA-4948) + Ibrutinib in R/R Primary CNS Lymphoma
Grommes C, Nowakowski G, Rosenthal A, Lunning M, Ramchandren R, Regales L, Fowle M, Lane M, Wang C, Omuro A, Leslie L, Soussain C, Dabrowska-Iwanicka A, Ferreri A, Tun H. Trial in Progress: An Open-Label Expansion Trial Evaluating the Safety, PK/PD, and Clinical Activity of Emavusertib (CA-4948) + Ibrutinib in R/R Primary CNS Lymphoma. Blood 2023, 142: 3143. DOI: 10.1182/blood-2023-190391.Peer-Reviewed Original ResearchPrimary central nervous system lymphomaInterleukin-1 receptor-associated kinase 4FMS-like tyrosine kinase 3Toll-like receptorsExpansion cohortPCNSL patientsDisease progressionRefractory primary central nervous system lymphomaDiagnosis of PCNSLCentral nervous system lymphomaPathogenesis of PCNSLSafety/tolerabilityOpen-label trialBlood-brain barrier penetrationPrimary CNS lymphomaSufficient blood-brain barrier penetrationNervous system lymphomaInitial clinical dataKey inclusion criteriaPotent oral inhibitorCentral nervous systemBrain barrier penetrationPK/PDTyrosine kinase 3Further preclinical studies
2019
Residual Tumor Volume, Cell Volume Fraction, and Tumor Cell Kill During Fractionated Chemoradiation Therapy of Human Glioblastoma using Quantitative Sodium MR Imaging
Thulborn KR, Lu A, Atkinson IC, Pauliah M, Beal K, Chan TA, Omuro A, Yamada J, Bradbury MS. Residual Tumor Volume, Cell Volume Fraction, and Tumor Cell Kill During Fractionated Chemoradiation Therapy of Human Glioblastoma using Quantitative Sodium MR Imaging. Clinical Cancer Research 2019, 25: 1226-1232. PMID: 30487127, PMCID: PMC7462306, DOI: 10.1158/1078-0432.ccr-18-2079.Peer-Reviewed Original ResearchConceptsResidual tumor volumeTumor cell killTissue sodium concentrationChemoradiation therapyOverall survivalHuman glioblastomaTumor volumeQuantitative sodium MR imagingCell killQuantitative sodium MRITumor cellsVariable tumor responseSodium MRITwo-compartment modelTumor resectionTumor responseDisease progressionSodium MR imagingTumor marginsMR imagingTherapyGlioblastomaTreatment volumeCancer cellsSodium concentration
2017
Cerebrospinal fluid circulating tumor cells (CSF CTC) for real-time patient monitoring and response to treatment.
Malani R, Fleisher M, Lin X, Omuro A, Groves M, Lin N, Melisko M, Lassman A, Jeyapalan S, Briggs S, DeAngelis L, Raizer J, Pentsova E. Cerebrospinal fluid circulating tumor cells (CSF CTC) for real-time patient monitoring and response to treatment. Journal Of Clinical Oncology 2017, 35: 11549-11549. DOI: 10.1200/jco.2017.35.15_suppl.11549.Peer-Reviewed Original ResearchCSF CTCsLeptomeningeal metastasesCellSearch systemTreatment responseCTC enumerationLM progressionCSF cytologyPhase I/II dose escalation trialDose-escalation trialPositive CSF cytologyCycles of treatmentCycle 1IT trastuzumabEscalation trialIntrathecal therapyRadiographic responseVentricular reservoirRadiographic worseningDisease progressionEarly biomarkersCerebrospinal fluidDay 1Colon cancerPotential biomarkersDiagnostic markerOS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Zwirtes R, Sampson J. OS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143. Neuro-Oncology 2017, 19: iii13-iii13. PMCID: PMC5463686, DOI: 10.1093/neuonc/nox036.044.Peer-Reviewed Original ResearchTreatment-related AEsAdverse eventsCheckMate 143Standard radiotherapyDisease progressionFirst prospective clinical trialHerpes simplex virus encephalitisTreatment-related adverse eventsTolerability of nivolumabTreatment-related deathsImmune checkpoint inhibitorsSimplex virus encephalitisDeath-1 receptorNew safety signalsPhase 2/3 studyProspective clinical trialsImmune cell infiltrationNovel therapeutic optionsMonoclonal antibody inhibitorMultiple cancer typesConcurrent temozolomideUnmethylated MGMTAdjuvant temozolomideCheckpoint inhibitorsRadiographic progressionPhase I trial of aflibercept (VEGF trap) with radiation therapy and concomitant and adjuvant temozolomide in patients with high-grade gliomas
Nayak L, de Groot J, Wefel JS, Cloughesy TF, Lieberman F, Chang SM, Omuro A, Drappatz J, Batchelor TT, DeAngelis LM, Gilbert MR, Aldape KD, Yung AW, Fisher J, Ye X, Chen A, Grossman S, Prados M, Wen PY. Phase I trial of aflibercept (VEGF trap) with radiation therapy and concomitant and adjuvant temozolomide in patients with high-grade gliomas. Journal Of Neuro-Oncology 2017, 132: 181-188. PMID: 28116649, PMCID: PMC5588922, DOI: 10.1007/s11060-016-2357-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, AlkylatingBrain NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyDacarbazineDrug Therapy, CombinationFemaleGliomaHumansMaleMiddle AgedNeuropsychological TestsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTemozolomideTreatment OutcomeVascular Endothelial Growth Factor AConceptsHigh-grade gliomasPhase I trialI trialArm 2Arm 1Anti-vascular endothelial growth factor therapyAdult Brain Tumor ConsortiumEndothelial growth factor therapyRecombinant human fusion proteinGrowth factorFull treatment courseGrowth factor therapyPlacental growth factorSoluble decoy receptorHuman fusion proteinKPS 90Primary endpointFactor therapyDay regimenMedian ageTreatment courseArm 3Disease progressionMedian numberRadiation therapy
2015
NIMG-17CENTRAL NEUROPATHOLOGY REVIEW TO ASSIST IN THE EVALUATION OF IMMUNE-RELATED TREATMENT CHANGES VERSUS DISEASE PROGRESSION IN CHECKMATE-143
Ramkissoon S, Sampson J, Vlahovic G, Sahebjam S, Omuro A, Baehring J, Latek R, Vandeloise E, Coric V, Cloughesy T, Lim M, Reardon D, Ligon K. NIMG-17CENTRAL NEUROPATHOLOGY REVIEW TO ASSIST IN THE EVALUATION OF IMMUNE-RELATED TREATMENT CHANGES VERSUS DISEASE PROGRESSION IN CHECKMATE-143. Neuro-Oncology 2015, 17: v156-v157. PMCID: PMC4639040, DOI: 10.1093/neuonc/nov225.17.Peer-Reviewed Original Research
2014
AT-07A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: PATIENT REPORTED OUTCOMES (PRO) FROM A CERN CLINICAL TRIAL
Armstrong T, Vera-Bolanos E, Gilbert M, Yuan Y, Wani K, Wu J, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Aldape K, Mendoza T. AT-07A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: PATIENT REPORTED OUTCOMES (PRO) FROM A CERN CLINICAL TRIAL. Neuro-Oncology 2014, 16: v9-v9. PMCID: PMC4217844, DOI: 10.1093/neuonc/nou237.7.Peer-Reviewed Original ResearchDose-dense temozolomideProgression-free survivalSymptom burdenClinical trialsDisease progressionRecurrent ependymomaFirst prospective clinical trialMedian progression-free survivalPatient Reported Outcome MeasuresPhase II studyOverall symptom burdenProspective clinical trialsPrimary CNS tumorCycle 6Majority of symptomsDry mouthFree survivalPrimary endpointRecurrent diseaseSymptom benefitCNS tumorII studyTreatment courseSymptom interferenceVision changes
2012
Chemotherapy-related magnetic resonance imaging abnormalities mimicking disease progression following intraventricular liposomal cytarabine and high dose methotrexate for neurolymphomatosis
Pentsova E, Rosenblum M, Holodny A, Palomba ML, Omuro A. Chemotherapy-related magnetic resonance imaging abnormalities mimicking disease progression following intraventricular liposomal cytarabine and high dose methotrexate for neurolymphomatosis. Leukemia & Lymphoma 2012, 53: 1620-1622. PMID: 22242822, DOI: 10.3109/10428194.2012.656632.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic AgentsAutopsyBrainBrain InjuriesChlorambucilCytarabineDisease ProgressionFatal OutcomeHumansInjections, SpinalLeukemia, Lymphocytic, Chronic, B-CellMagnetic Resonance ImagingMaleMethotrexateNervous System DiseasesPositron-Emission TomographyRecurrenceWaldenstrom Macroglobulinemia
2011
A phase II study of the Ras-MAPK signaling pathway inhibitor TLN-4601 in patients with glioblastoma at first progression
Mason WP, Belanger K, Nicholas G, Vallières I, Mathieu D, Kavan P, Desjardins A, Omuro A, Reymond D. A phase II study of the Ras-MAPK signaling pathway inhibitor TLN-4601 in patients with glioblastoma at first progression. Journal Of Neuro-Oncology 2011, 107: 343-349. PMID: 22048878, DOI: 10.1007/s11060-011-0747-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsBrain NeoplasmsChromatography, LiquidDibenzazepinesErbB ReceptorsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGlioblastomaHumansInfusions, IntraventricularKaplan-Meier EstimateMagnetic Resonance ImagingMaleMiddle AgedPTEN PhosphohydrolaseTandem Mass SpectrometryConceptsPharmacokinetic evaluationProgressive glioblastomaFirst progressionM2/dayPhase II studyMR scansPhase II trialContinuous intravenous administrationBlood-brain barrierLack of efficacyPeripheral benzodiazepine receptorEvaluable patientsStable diseaseII trialRadiographic progressionAdverse eventsII studyRecurrent glioblastomaDisease progressionDrug levelsIntravenous administrationBiomarker assessmentPatientsAnimal modelsBenzodiazepine receptors
2008
What is the place of bevacizumab and irinotecan in the treatment of glioblastoma and other malignant gliomas?
Omuro AM, Delattre JY. What is the place of bevacizumab and irinotecan in the treatment of glioblastoma and other malignant gliomas? Current Opinion In Neurology 2008, 21: 717-719. PMID: 18989118, DOI: 10.1097/wco.0b013e3283184625.Peer-Reviewed Original ResearchConceptsMalignant gliomasOverall survivalClinical trialsProspective phase II trialPlace of bevacizumabProgression-free survivalPhase II trialNew treatment strategiesHigh response rateTreatment of glioblastomaII trialRecurrent diseaseSalvage treatmentCytotoxic chemotherapyMost patientsConventional radiographic methodsDisease progressionHistorical controlsSurvival resultsRadiographic criteriaTreatment strategiesBevacizumabResponse rateNew treatmentsGliomas
2005
Salvage temozolomide for prior temozolomide responders
Franceschi E, Omuro AM, Lassman AB, Demopoulos A, Nolan C, Abrey LE. Salvage temozolomide for prior temozolomide responders. Cancer 2005, 104: 2473-2476. PMID: 16270316, DOI: 10.1002/cncr.21564.Peer-Reviewed Original ResearchConceptsDisease recurrenceRecurrent/progressive gliomaInitial disease recurrencePotential hematologic complicationsSubsequent salvage therapyFirst-line therapyProgression-free survivalTime of diagnosisLow-grade oligodendrogliomasWarrants further investigationSalvage therapyStable diseaseHematologic complicationsObjective responseRadiographic responseMedian ageRetrospective reviewDisease progressionTMZ treatmentAnaplastic astrocytomaPatientsProgressive gliomasRecurrenceTemozolomideSame agentsChemoradiotherapy for primary CNS lymphoma
Omuro AM, DeAngelis LM, Yahalom J, Abrey LE. Chemoradiotherapy for primary CNS lymphoma. Neurology 2005, 64: 69-74. PMID: 15642906, DOI: 10.1212/01.wnl.0000148641.98241.5e.Peer-Reviewed Original ResearchConceptsPrimary CNS lymphomaLong-term outcomesComplete responsePartial responseCNS lymphomaMedian Karnofsky Performance Scale scoreMedian disease-free survivalProspective phase II trialKarnofsky Performance Scale scoreIncidence of neurotoxicityWhole brain radiotherapyMedian overall survivalDisease-free survivalPhase II trialYear of diagnosisPerformance Scale scoreChemotherapy regimenChemotherapy regimensFifteen patientsFirst relapseII trialMinor complicationsOverall survivalModality treatmentDisease progression