2024
A phase (Ph) 0/Ia study of brigimadlin concentration in brain tissue and a non-randomized, open-label, dose escalation study of brigimadlin in combination with radiotherapy (RT) in patients (pts) with newly diagnosed glioblastoma (GBM).
Sarkaria J, Mrugala M, Jaeckle K, Burns T, Vaubel R, Parney I, Chaichana K, Clement P, Martinez-Garcia M, Sepulveda Sanchez J, Omuro A, Pronk L, Ross H, Teufel M, Hesse R, Grempler R, Galanis E. A phase (Ph) 0/Ia study of brigimadlin concentration in brain tissue and a non-randomized, open-label, dose escalation study of brigimadlin in combination with radiotherapy (RT) in patients (pts) with newly diagnosed glioblastoma (GBM). Journal Of Clinical Oncology 2024, 42: 2017-2017. DOI: 10.1200/jco.2024.42.16_suppl.2017.Peer-Reviewed Original ResearchNon-contrast-enhancedOpen-labelContrast enhancementMGMT promoter unmethylated glioblastomaUnbound concentrationsCalculated unbound concentrationsNewly diagnosed GBMDose-escalation studyMaximum tolerated doseTumor cell apoptosisSingle-arm trialMDM2-p53 antagonistsRestore wild-typeBrain tissueUnmethylated glioblastomaBrain tumor tissueEscalation studyDiagnosed glioblastomaTolerated doseP53 target gene expressionPrimary endpointIDH-wtSolid tumorsTumor tissuesXenograft model
2023
CTNI-41. PHASE II AND PHASE 0 RESULTS OF ABTC 1801: A MULTI-ARM CLINICAL TRIAL OF THE PARP INHIBITOR PAMIPARIB WITH VERY LOW DOSE METRONOMIC TEMOZOLOMIDE IN RECURRENT IDH MUTANT GLIOMAS
Schiff D, Bindra R, Li J, Ye X, Ellingson B, Walbert T, Campian J, Nabors B, Lieberman F, Ozer B, Desai A, Omuro A, Wen P, Desideri S, Danda N, Grossman S. CTNI-41. PHASE II AND PHASE 0 RESULTS OF ABTC 1801: A MULTI-ARM CLINICAL TRIAL OF THE PARP INHIBITOR PAMIPARIB WITH VERY LOW DOSE METRONOMIC TEMOZOLOMIDE IN RECURRENT IDH MUTANT GLIOMAS. Neuro-Oncology 2023, 25: v84-v84. PMCID: PMC10639307, DOI: 10.1093/neuonc/noad179.0323.Peer-Reviewed Original ResearchObjective response rateArm AMetronomic temozolomideArm BGrade 3Non-enhancing tumorMeaningful objective response rateTumor/plasma ratioCumulative hematologic toxicityGrade 3 anemiaGrade 3 thrombocytopeniaGrade 4 neutropeniaPhase II componentArm clinical trialPhase IIKPS 90Median PFSHematologic toxicityPrimary endpointAlkylator therapyProgressive diseaseARM patientsMedian ageBRCAness phenotypeClinical trialsMulticenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma
Fanucci K, Pilat M, Shyr D, Shyr Y, Boerner S, Li J, Durecki D, Drappatz J, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma. Cancer Research Communications 2023, 3: 192-201. PMID: 36968138, PMCID: PMC10035510, DOI: 10.1158/2767-9764.crc-22-0436.Peer-Reviewed Original ResearchConceptsProgression-free survivalMedian progression-free survivalProlonged stable diseaseStable diseasePhase II trialGrade 4 tumorsII trialOlaparib monotherapyGrade 2Multicenter phase 2 trialSingle-arm phase II trialWorld Health Organization classificationMedian overall survivalNeuro-Oncology criteriaPhase 2 trialOverall response rateFuture patient stratificationMutant gliomasPARP inhibitor olaparibEvaluable patientsPrimary endpointOverall survivalProgressive diseaseSelect patientsClinical benefit
2022
Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma.
Fanucci K, Pilat M, Shah R, Boerner S, Li J, Durecki D, Drappatz J, Collichio F, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Bao X, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma. Journal Of Clinical Oncology 2022, 40: 2035-2035. DOI: 10.1200/jco.2022.40.16_suppl.2035.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalStable diseaseDuration of responseOverall response ratePARP inhibitorsOverall survivalStandard therapyOlaparib monotherapyMulticenter phase 2 trialCDKN2A deletionClinical predictive markersGrade 3 lymphopeniaProlonged stable diseasePhase 2 trialGrade 4 tumorsFuture patient stratificationRecent preclinical studiesHigh-grade gliomasNovel drug combinationsContrast-enhancing gliomasEligible ptsEvaluable ptsRecent histologyPrimary endpointPhase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter
Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro-Oncology 2022, 24: 1935-1949. PMID: 35511454, PMCID: PMC9629431, DOI: 10.1093/neuonc/noac116.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survivalMGMT promoterBaseline corticosteroidsTreatment-related adverse event ratesImmune checkpoint inhibitor nivolumabNew safety signalsPhase III trialsAdverse event ratesCheckpoint inhibitor nivolumabCare radiotherapyInhibitor nivolumabPrimary endpointIII trialsSame regimenExperience recurrenceNivolumabSafety signalsPlaceboPatientsRadiotherapyTemozolomideEvent ratesMonthsPhase IIIRadiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial
Omuro A, Brandes AA, Carpentier AF, Idbaih A, Reardon DA, Cloughesy T, Sumrall A, Baehring J, van den Bent M, Bähr O, Lombardi G, Mulholland P, Tabatabai G, Lassen U, Sepulveda JM, Khasraw M, Vauleon E, Muragaki Y, Di Giacomo AM, Butowski N, Roth P, Qian X, Fu AZ, Liu Y, Potter V, Chalamandaris AG, Tatsuoka K, Lim M, Weller M. Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. Neuro-Oncology 2022, 25: 123-134. PMID: 35419607, PMCID: PMC9825306, DOI: 10.1093/neuonc/noac099.Peer-Reviewed Original ResearchConceptsOverall survivalUnmethylated MGMT promoterMedian OSPrimary endpointInternational randomized phase III trialTreatment-related adverse event ratesMedian progression-free survivalRandomized phase III trialMGMT promoterEfficacy of nivolumabLonger median OSMedian overall survivalNew safety signalsProgression-free survivalAddition of temozolomideAdverse event ratesPhase III trialsUse of temozolomideStandard of careStudy treatment armsImproved OSIII trialsTreatment armsStandard radiotherapyNivolumabPhase I/randomized phase II trial of TRC105 plus bevacizumab versus bevacizumab in recurrent glioblastoma: North Central Cancer Treatment Group N1174 (Alliance)
Galanis E, Anderson SK, Twohy E, Butowski NA, Hormigo A, Schiff D, Omuro A, Jaeckle KA, Kumar S, Kaufmann TJ, Geyer S, Kumthekar PU, Campian J, Giannini C, Buckner JC, Wen PY. Phase I/randomized phase II trial of TRC105 plus bevacizumab versus bevacizumab in recurrent glioblastoma: North Central Cancer Treatment Group N1174 (Alliance). Neuro-Oncology Advances 2022, 4: vdac041. PMID: 35664553, PMCID: PMC9154335, DOI: 10.1093/noajnl/vdac041.Peer-Reviewed Original ResearchProgression-free survivalRandomized phase II trialPhase II trialBevacizumab monotherapyRecurrent glioblastomaII trialTreatment armsMedian progression-free survivalLimited effective treatment optionsPhase IQuestionable survival benefitEarly clinical dataEffective treatment optionPhase IIQuality of lifeCombination armPrimary endpointAdverse eventsSurvival benefitLife scoresPoor prognosisTreatment optionsMechanisms of resistanceBevacizumabClinical dataNivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143
Omuro A, Reardon DA, Sampson JH, Baehring J, Sahebjam S, Cloughesy TF, Chalamandaris AG, Potter V, Butowski N, Lim M. Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. Neuro-Oncology Advances 2022, 4: vdac025. PMID: 35402913, PMCID: PMC8989388, DOI: 10.1093/noajnl/vdac025.Peer-Reviewed Original ResearchSafety/tolerabilityNew safety signalsOverall survivalCheckMate 143Median OSSafety signalsGrade 3/4 treatment-related adverse eventsTreatment-related adverse eventsEfficacy of nivolumabImmune checkpoint inhibitionMedian overall survivalPhase 1 cohortFirst-line treatmentPart APrimary endpointSecondary endpointsAdverse eventsCheckpoint inhibitionPatientsI cohortNivolumabTemozolomideRadiotherapyMonthsPart B
2019
ATIM-47. NIVOLUMAB VS BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: EXPLORATORY ANALYSIS OF MGMT METHYLATION STATUS AND BASELINE CORTICOSTEROID USE
Weller M, Reardon D, Brandes A, Sampson J, Mulholland P, Wick A, Baehring J, Ahluwalia M, Roth P, Bähr O, Phuphanich S, Sepulveda J, de Souza P, Sahebjam S, Potter V, Tatsuoka K, Taitt C, Zwirtes R, Omuro A, Lim M. ATIM-47. NIVOLUMAB VS BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: EXPLORATORY ANALYSIS OF MGMT METHYLATION STATUS AND BASELINE CORTICOSTEROID USE. Neuro-Oncology 2019, 21: vi12-vi12. PMCID: PMC6847600, DOI: 10.1093/neuonc/noz175.045.Peer-Reviewed Original ResearchMedian overall survivalBaseline corticosteroid useCorticosteroid useBaseline corticosteroidsMGMT methylation statusRecurrent glioblastomaUnmethylated tumorsMultivariable Cox proportional hazards model analysisCox proportional hazards model analysisLonger median overall survivalProportional hazards model analysisBevacizumab-treated patientsLimited survival benefitNivolumab-treated patientsSubgroup of patientsExploratory subgroup analysisHazards model analysisMethyltransferase promoter methylation statusDNA methyltransferase promoter methylation statusMethylation statusMGMT promoter statusTemozolomide chemoradiotherapyFirst recurrencePrimary endpointOverall survival
2018
RARE-24. OBJECTIVE RESPONSE AND CLINICAL BENEFIT IN RECURRENT EPENDYMOMA IN ADULTS: FINAL REPORT OF CERN 08-02: A PHASE II STUDY OF DOSE-DENSE TEMOZOLOMIDE AND LAPATINIB
Armstrong T, Yuan Y, Wu J, Mendoza T, Vera E, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Aldape K, Gilbert M. RARE-24. OBJECTIVE RESPONSE AND CLINICAL BENEFIT IN RECURRENT EPENDYMOMA IN ADULTS: FINAL REPORT OF CERN 08-02: A PHASE II STUDY OF DOSE-DENSE TEMOZOLOMIDE AND LAPATINIB. Neuro-Oncology 2018, 20: vi241-vi241. PMCID: PMC6217700, DOI: 10.1093/neuonc/noy148.998.Peer-Reviewed Original ResearchDose-dense temozolomideObjective responseClinical benefitRecurrent ependymomaAdult clinical trialsModerate-severe painStable disease rateStandard salvage regimenPhase II studyRole of chemotherapyProgression-free survivalDisease-related symptomsDaily lapatinibMedian KPSMedian PFSPFS ratesPrior relapseSalvage regimenAutonomic dysfunctionFree survivalPrimary endpointRecurrent diseaseAdult patientsCombination regimenII study
2017
Phase 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
Orally administered colony stimulating factor 1 receptor inhibitor PLX3397 in recurrent glioblastoma: an Ivy Foundation Early Phase Clinical Trials Consortium phase II study
Butowski N, Colman H, De Groot JF, Omuro AM, Nayak L, Wen PY, Cloughesy TF, Marimuthu A, Haidar S, Perry A, Huse J, Phillips J, West BL, Nolop KB, Hsu HH, Ligon KL, Molinaro AM, Prados M. Orally administered colony stimulating factor 1 receptor inhibitor PLX3397 in recurrent glioblastoma: an Ivy Foundation Early Phase Clinical Trials Consortium phase II study. Neuro-Oncology 2015, 18: 557-564. PMID: 26449250, PMCID: PMC4799682, DOI: 10.1093/neuonc/nov245.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAminopyridinesBiomarkers, TumorBlood-Brain BarrierBrain NeoplasmsCohort StudiesFemaleFollow-Up StudiesGlioblastomaHumansImmunoenzyme TechniquesMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisPyrrolesReceptors, Granulocyte-Macrophage Colony-Stimulating FactorTissue DistributionTumor BurdenConceptsPhase II studyII studyRecurrent glioblastomaTumor tissueMedian drug levelsPrimary efficacy endpointProgression-free survivalBlood-brain barrierPretreatment baseline valuesBlood-tumor barrierExploratory endpointsInhibitor PLX3397Efficacy endpointPrimary endpointSecondary endpointsObjective responseSurgical resectionOral dosePharmacodynamic changesPharmacodynamic measuresTumor burdenDrug exposureTissue pharmacokineticsDrug levelsStem cell factorMulticenter phase 2 study of patupilone for recurrent or progressive brain metastases from non–small cell lung cancer
Nayak L, DeAngelis LM, Robins HI, Govindan R, Gadgeel S, Kelly K, Rigas JR, Peereboom DM, Rosenfeld SS, Muzikansky A, Zheng M, Urban P, Abrey LE, Omuro A, Wen PY. Multicenter phase 2 study of patupilone for recurrent or progressive brain metastases from non–small cell lung cancer. Cancer 2015, 121: 4165-4172. PMID: 26308485, PMCID: PMC5941922, DOI: 10.1002/cncr.29636.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerProgressive brain metastasesBrain metastasesCell lung cancerAdverse eventsStudy drugLung cancerGrade 3/4 adverse eventsMulticenter phase 2 studyNSCLC brain metastasesSteady-state distribution volumePhase 1/2 studyRecurrent brain metastasesPhase 2 studyProgression-free survivalFirst prospective studyConcentration-time curvePrimary endpointAdult patientsOverall survivalPulmonary embolismMedian agePeripheral neuropathyMedian timeProspective studyMethotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial
Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrié M, del Rio M, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy M, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. The Lancet Haematology 2015, 2: e251-e259. PMID: 26688235, DOI: 10.1016/s2352-3026(15)00074-5.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCentral Nervous System NeoplasmsCytarabineDacarbazineDisease-Free SurvivalFemaleHumansLymphomaMaleMethotrexateMiddle AgedProcarbazineProspective StudiesQuality of LifeTemozolomideTreatment OutcomeVincristineConceptsPrimary CNS lymphomaProgression-free survivalKarnofsky Performance Scale scoreCytarabine groupPhase 2 trialCNS lymphomaPerformance Scale scoreTemozolomide groupElderly populationScale scoreMedian progression-free survivalPhase 2 trial designCommon grade 3Methotrexate-based regimensProphylactic G-CSFMedian overall survivalStandard chemotherapy regimenPoor prognosis patientsQuality of lifeChemotherapy regimenEfficacy endpointPrimary endpointPrognosis patientsElderly patientsImmunocompetent patients
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 changesAT-23A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: A CERN CLINICAL TRIAL
Gilbert M, Yuan Y, Wani K, Wu J, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Armstrong T, Aldape K. AT-23A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: A CERN CLINICAL TRIAL. Neuro-Oncology 2014, 16: v13-v13. PMCID: PMC4217801, DOI: 10.1093/neuonc/nou237.23.Peer-Reviewed Original ResearchDose-dense temozolomideClinical trialsPredictive markerFirst prospective clinical trialPhase II studyPrimary CNS tumorsProspective clinical trialsPossible predictive markerPotential predictive markerPatient reported outcomesSubsequent clinical trialsMGMT promoter statusMedian KPSMedian progressionPrimary endpointRecurrent diseaseII studyOverall survivalSymptom burdenMedian ageInitial treatmentCNS tumorsExtensive resectionStandard treatmentPRO collectionPhase II Study of Bevacizumab, Temozolomide, and Hypofractionated Stereotactic Radiotherapy for Newly Diagnosed Glioblastoma
Omuro A, Beal K, Gutin P, Karimi S, Correa DD, Kaley TJ, DeAngelis LM, Chan TA, Gavrilovic IT, Nolan C, Hormigo A, Lassman AB, Mellinghoff I, Grommes C, Reiner AS, Panageas KS, Baser RE, Tabar V, Pentsova E, Sanchez J, Barradas-Panchal R, Zhang J, Faivre G, Brennan CW, Abrey LE, Huse JT. Phase II Study of Bevacizumab, Temozolomide, and Hypofractionated Stereotactic Radiotherapy for Newly Diagnosed Glioblastoma. Clinical Cancer Research 2014, 20: 5023-5031. PMID: 25107913, PMCID: PMC4523080, DOI: 10.1158/1078-0432.ccr-14-0822.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiopsyBrain NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyDacarbazineFemaleGlioblastomaHumansMagnetic Resonance ImagingMaleMiddle AgedRadiosurgeryTemozolomideTreatment OutcomeYoung AdultConceptsObjective response rateOverall survivalRadiotherapy schedulesMedian overall survivalPhase II studyHypofractionated Stereotactic RadiotherapyPhase II trialApparent diffusion coefficient ratioRelative cerebral blood volumeDynamic susceptibility contrast perfusion MRICerebral blood volumeNeuropsychological test scoresMedian PFSPersistent hypermetabolismAdjuvant temozolomidePrimary endpointII studyII trialPoor OSStandard dosesFDG-PETPrognostic valuePoor prognosisHistorical controlsTumor volumePhase II trial of sunitinib for recurrent and progressive atypical and anaplastic meningioma
Kaley TJ, Wen P, Schiff D, Ligon K, Haidar S, Karimi S, Lassman AB, Nolan CP, DeAngelis LM, Gavrilovic I, Norden A, Drappatz J, Lee EQ, Purow B, Plotkin SR, Batchelor T, Abrey LE, Omuro A. Phase II trial of sunitinib for recurrent and progressive atypical and anaplastic meningioma. Neuro-Oncology 2014, 17: 116-121. PMID: 25100872, PMCID: PMC4483051, DOI: 10.1093/neuonc/nou148.Peer-Reviewed Original ResearchConceptsVascular endothelial growth factor receptorPhase II trialWorld Health OrganizationGrowth factor receptorII trialPrimary endpointOverall survivalExploratory cohortIntratumoral hemorrhageGrade 3Small molecule tyrosine kinase inhibitorsSingle-arm phase II trialMalignant meningioma patientsRadiographic response rateMedian overall survivalEffective medical therapyProgression-free survivalFactor receptorEndothelial growth factor receptorPlatelet-derived growth factor receptorTyrosine kinase inhibitorsExpression of VEGFR2MR perfusion imagingHigh-grade meningiomasMedian PFS
2013
Phase II trial of the phosphatidyinositol-3 kinase (PI3K) inhibitor BKM120 in recurrent glioblastoma (GBM).
Wen P, Yung W, Mellinghoff I, Lamborn K, Ramkissoon S, Cloughesy T, Rinne M, Omuro A, DeAngelis L, Gilbert M, Chi A, Batchelor T, Colman H, Chang S, Massacesi C, DiTomaso E, Prados M, Reardon D, Ligon K. Phase II trial of the phosphatidyinositol-3 kinase (PI3K) inhibitor BKM120 in recurrent glioblastoma (GBM). Journal Of Clinical Oncology 2013, 31: 2015-2015. DOI: 10.1200/jco.2013.31.15_suppl.2015.Peer-Reviewed Original ResearchPI3K pathwayRecurrent glioblastomaK pathwayPan-class I PI3K inhibitorMajor grade 3/4 toxicitiesEnzyme-inducing antiepileptic drugsAdequate bone marrowGrade 3/4 toxicitiesPhase II studyPhase II trialProgression-free survivalClinical Trials ConsortiumRecurrent GBM patientsAdditional eligibility criteriaPotential therapeutic targetReduction of pAKTWhole-exome sequencingPI3K inhibitorsAnalysis of tumorsRadiologic progressionUnresectable glioblastomaII trialPrimary endpointRecurrent diseaseII studyMulticenter randomized phase II trial of methotrexate (MTX) and temozolomide (TMZ) versus MTX, procarbazine, vincristine, and cytarabine for primary CNS lymphoma (PCNSL) in the elderly: An Anocef and Goelams Intergroup study.
Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Maire J, Benouaich Amiel A, Lebouvier-Sadot S, Gyan E, Barrie M, Sierra del Rio M, Gonzalez A, Houillier C, Tanguy M, Hoang-Xuan K. Multicenter randomized phase II trial of methotrexate (MTX) and temozolomide (TMZ) versus MTX, procarbazine, vincristine, and cytarabine for primary CNS lymphoma (PCNSL) in the elderly: An Anocef and Goelams Intergroup study. Journal Of Clinical Oncology 2013, 31: 2032-2032. DOI: 10.1200/jco.2013.31.15_suppl.2032.Peer-Reviewed Original ResearchPrimary CNS lymphomaAbnormal liver function testsCycles of methotrexateProphylactic G-CSFWhole brain radiotherapyLiver function testsPhase II trialProspective multicenter studyBaseline cognitive impairmentQuality of lifePre-treatment characteristicsCommon toxicitiesCytarabine consolidationCNS lymphomaEfficacy endpointII trialPrimary endpointBrain radiotherapyElderly patientsObjective responseStandard chemotherapyCR rateFunction testsIntergroup studyMulticenter study