2021
CTNI-18. PHASE I AND PRELIMINARY PHASE 0 RESULTS OF ABTC 1801: A MULTI-ARM CLINICAL TRIAL OF THE PARP INHIBITOR PAMIPARIB (BGB290) 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 L, Lieberman F, Ozer B, Desai A, Omuro A, Wen P, Desideri S, Fisher J, Grossman S. CTNI-18. PHASE I AND PRELIMINARY PHASE 0 RESULTS OF ABTC 1801: A MULTI-ARM CLINICAL TRIAL OF THE PARP INHIBITOR PAMIPARIB (BGB290) WITH VERY LOW DOSE METRONOMIC TEMOZOLOMIDE IN RECURRENT IDH MUTANT GLIOMAS. Neuro-Oncology 2021, 23: vi63-vi63. DOI: 10.1093/neuonc/noab196.243.Peer-Reviewed Original ResearchMetronomic temozolomidePhase IFavorable brain penetrationDose level 1Phase II studyGrade 2 neutropeniaArm clinical trialKPS 90Inadequate dosingPrior radiotherapyAlkylator therapyHematological toxicityII studyMedian ageAdditional patientsStudy treatmentBrain penetrationRelapse 3BRCAness phenotypeClinical trialsIDH1 mutant gliomasSurgical armTemozolomide dosePreclinical studiesAnaplastic astrocytoma
2020
A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma
Gilbert MR, Yuan Y, Wu J, Mendoza T, Vera E, Omuro A, Lieberman F, Robins HI, Gerstner ER, Wu J, Wen PY, Mikkelsen T, Aldape K, Armstrong TS. A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma. Neuro-Oncology 2020, 23: 468-477. PMID: 33085768, PMCID: PMC7992893, DOI: 10.1093/neuonc/noaa240.Peer-Reviewed Original ResearchConceptsProgression-free survivalDose-dense temozolomideMedian progression-free survivalAdult patientsObjective responseSymptom burdenClinical trialsRecurrent ependymomaMD Anderson Symptom Inventory-Brain TumorProspective phase II clinical trialMedian Karnofsky performance statusPhase II clinical trialDemonstrated clinical activityModerate-severe painPatients age 18Phase II studyKarnofsky performance statusProspective clinical trialsSpinal cord tumorsStandard medical treatmentPrimary outcome measureSpinal cord ependymomasDisease-related symptomsExpression of ErbB2Daily lapatinib
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
Multicenter phase II study of temozolomide and myeloablative chemotherapy with autologous stem cell transplant for newly diagnosed anaplastic oligodendroglioma
Thomas AA, Abrey LE, Terziev R, Raizer J, Martinez NL, Forsyth P, Paleologos N, Matasar M, Sauter CS, Moskowitz C, Nimer SD, DeAngelis LM, Kaley T, Grimm S, Louis DN, Cairncross JG, Panageas KS, Briggs S, Faivre G, Mohile NA, Mehta J, Jonsson P, Chakravarty D, Gao J, Schultz N, Brennan CW, Huse JT, Omuro A. Multicenter phase II study of temozolomide and myeloablative chemotherapy with autologous stem cell transplant for newly diagnosed anaplastic oligodendroglioma. Neuro-Oncology 2017, 19: 1380-1390. PMID: 28472509, PMCID: PMC5596171, DOI: 10.1093/neuonc/nox086.Peer-Reviewed Original ResearchConceptsAutologous stem cell transplantProgression-free survivalHigh-dose chemotherapyStem cell transplantAnaplastic oligodendrogliomaAnaplastic oligoastrocytomaHDC-ASCTMulticenter phase II studyMyeloablative high-dose chemotherapyChemotherapy-based approachesCycles of temozolomideOverall survival 93Phase II studyRadiation-related toxicityUnexpected adverse eventsNext-generation sequencingChemotherapy-sensitive tumorsWide molecular heterogeneityToxic deathsAdverse eventsII studyMyeloablative chemotherapyProspective trialIntact patientsCell transplant
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 factor
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-47PHASE I TRIAL OF INTRATHECAL TRASTUZUMAB IN HER2 POSITIVE LEPTOMENINGEAL METASTASES
Raizer J, Pentsova E, Omuro A, Lin N, Nayak L, Quant E, Kumthekar P. AT-47PHASE I TRIAL OF INTRATHECAL TRASTUZUMAB IN HER2 POSITIVE LEPTOMENINGEAL METASTASES. Neuro-Oncology 2014, 16: v19-v19. PMCID: PMC4217826, DOI: 10.1093/neuonc/nou237.46.Peer-Reviewed Original ResearchHER2-positive breast cancerPositive breast cancerLeptomeningeal metastasesDose levelsBreast cancerIntrathecal trastuzumabCentral nervous system penetrationPhase I clinical trialPhase II studyHumanized monoclonal antibodyIT trastuzumabMedian KPSII studyProgressive diseaseI trialMedian ageOmmaya reservoirCSF levelsAnaplastic ependymomaClinical trialsPatientsPK dataTherapeutic levelsIts TreatmentTrastuzumabAT-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 THE PHOSPHATIDYINOSITOL-3 KINASE (PI3K) INHIBITOR BUPARLISIB (BKM120) IN RECURRENT GLIOBLASTOMA CONDUCTED BY THE IVY FOUNDATION EARLY PHASE CLINICAL TRIALS CONSORTIUM
Wen P, Wen P, Yung W, Mellinghoff I, Ramkissoon S, Alexander B, Rinne M, Colman H, Omuro A, DeAngelis L, Gilbert M, DeGroot J, Cloughesy T, Lee E, Nayak L, S. A, Batchelor T, Chang S, Prados M, Reardon D, Ligon K. PHASE II TRIAL OF THE PHOSPHATIDYINOSITOL-3 KINASE (PI3K) INHIBITOR BUPARLISIB (BKM120) IN RECURRENT GLIOBLASTOMA CONDUCTED BY THE IVY FOUNDATION EARLY PHASE CLINICAL TRIALS CONSORTIUM. Neuro-Oncology 2014, 16: iii47-iii47. PMCID: PMC4144634, DOI: 10.1093/neuonc/nou209.20.Peer-Reviewed Original ResearchPI3K pathwayCohort 2Cohort 1Pan-class I PI3K inhibitorEnzyme-inducing antiepileptic drugsAdequate bone marrowGrade 4 toxicityGrowth of U87K pathwayGrade 3 toxicityPhase II studyPhase II trialRecurrent GBM patientsAdditional eligibility criteriaALT/ASTSingle-agent efficacyPotential therapeutic targetPI3K mutationsReduction of pAKTPI3K inhibitorsEvaluable patientsMedian OSMedian PFSPrior bevacizumabRadiologic progression
2013
Rituximab, Methotrexate, Procarbazine, and Vincristine Followed by Consolidation Reduced-Dose Whole-Brain Radiotherapy and Cytarabine in Newly Diagnosed Primary CNS Lymphoma: Final Results and Long-Term Outcome
Morris PG, Correa DD, Yahalom J, Raizer JJ, Schiff D, Grant B, Grimm S, Lai RK, Reiner AS, Panageas K, Karimi S, Curry R, Shah G, Abrey LE, DeAngelis LM, Omuro A. Rituximab, Methotrexate, Procarbazine, and Vincristine Followed by Consolidation Reduced-Dose Whole-Brain Radiotherapy and Cytarabine in Newly Diagnosed Primary CNS Lymphoma: Final Results and Long-Term Outcome. Journal Of Clinical Oncology 2013, 31: 3971-3979. PMID: 24101038, PMCID: PMC5569679, DOI: 10.1200/jco.2013.50.4910.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCentral Nervous System NeoplasmsChemoradiotherapyCranial IrradiationCytarabineDisease-Free SurvivalFemaleHumansLymphomaMaleMethotrexateMiddle AgedProcarbazineRituximabTimeTreatment OutcomeVincristineConceptsProgression-free survivalMedian progression-free survivalMedian overall survivalPrimary CNS lymphomaOverall survivalR-MPVComplete responseCNS lymphomaMedian Karnofsky performance scoreMulticenter phase II studyLong-term disease controlEnd pointApparent diffusion coefficientExploratory end pointsKarnofsky performance scorePhase II studyPrimary end pointWhole brain radiotherapyLong-term outcomesWhite matter changesHigh response rateInduction chemotherapyStandard WBRTBrain radiotherapyII studyPhase 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 studyAn Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (IN10-2.005)
Nayak L, Abrey L, DeAngelis L, Gadgeel S, Garst J, Govindan R, Kelly K, Omuro A, Peereboom D, Ramnath N, Reimers H, Rigas J, Robbins H, Rosenfeld S, Wen P. An Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (IN10-2.005). Neurology 2013, 80 DOI: 10.1212/wnl.80.7_supplement.in10-2.005.Peer-Reviewed Original ResearchAn Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (S56.002)
Nayak L, Abrey L, DeAngelis L, Gadgeel S, Garst J, Govindan R, Kelly K, Omuro A, Peereboom D, Ramnath N, Reimers H, Rigas J, Robbins H, Rosenfeld S, Wen P. An Open-Label, Multi-Center, Phase II Study of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients with Non-Small Cell Lung Cancer (NSCLC) (S56.002). Neurology 2013, 80 DOI: 10.1212/wnl.80.7_supplement.s56.002.Peer-Reviewed Original Research
2012
Multicenter phase II study of rituximab and temozolomide in recurrent primary central nervous system lymphoma
Nayak L, Abrey LE, Drappatz J, Gilbert MR, Reardon DA, Wen PY, Prados M, Deangelis LM, Omuro A, Consortium F. Multicenter phase II study of rituximab and temozolomide in recurrent primary central nervous system lymphoma. Leukemia & Lymphoma 2012, 54: 58-61. PMID: 22656234, PMCID: PMC4802006, DOI: 10.3109/10428194.2012.698736.Peer-Reviewed Original ResearchConceptsPrimary central nervous system lymphomaRecurrent primary central nervous system lymphomaCentral nervous system lymphomaNervous system lymphomaSystem lymphomaDay 1Prospective multicenter phase II trialMedian progression-free survivalMulticenter phase II studyMulticenter phase II trialAggressive salvage treatmentMedian overall survivalPhase II studyPhase II trialProgression-free survivalCycles of consolidationEvaluable patientsII trialSalvage treatmentII studyImmunocompetent patientsOverall survivalComplete responseRetrospective studyPatients
2011
Primary central nervous system lymphoma
Graber JJ, Omuro A. Primary central nervous system lymphoma. Current Opinion In Neurology 2011, 24: 633-640. PMID: 21968551, DOI: 10.1097/wco.0b013e32834cbdef.Peer-Reviewed Original ResearchConceptsPrimary central nervous system lymphomaCentral nervous system lymphomaReduced-dose radiotherapyProgression-free survivalNervous system lymphomaNeurotoxicity ratesSystem lymphomaChemotherapy-only treatmentHigh-dose methotrexateStem cell rescueWhole brain radiotherapyHigh-dose chemotherapyPhase II studyWorse cognitive outcomesChemotherapy regimenSalvage treatmentII studyOlder patientsOverall survivalBrain damageChemotherapyRadiotherapyAdditional neurotoxicityRoutine practiceNeuropsychological evaluationA 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