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 trials
2019
Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial
Wen PY, Touat M, Alexander BM, Mellinghoff IK, Ramkissoon S, McCluskey CS, Pelton K, Haidar S, Basu SS, Gaffey SC, Brown LE, Martinez-Ledesma JE, Wu S, Kim J, Wei W, Park MA, Huse JT, Kuhn JG, Rinne ML, Colman H, Agar NYR, Omuro AM, DeAngelis LM, Gilbert MR, de Groot JF, Cloughesy TF, S. A, Roberts TM, Zhao JJ, Lee EQ, Nayak L, Heath JR, Horky LL, Batchelor TT, Beroukhim R, Chang SM, Ligon AH, Dunn IF, Koul D, Young GS, Prados MD, Reardon DA, Yung WKA, Ligon KL. Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial. Journal Of Clinical Oncology 2019, 37: jco.18.01207. PMID: 30715997, PMCID: PMC6553812, DOI: 10.1200/jco.18.01207.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopyridinesAntineoplastic AgentsBrain NeoplasmsChemotherapy, AdjuvantDisease ProgressionEnzyme ActivationFemaleGlioblastomaHumansMaleMiddle AgedMorpholinesNeoadjuvant TherapyNeoplasm Recurrence, LocalPhosphatidylinositol 3-KinasePhosphoinositide-3 Kinase InhibitorsProgression-Free SurvivalTime FactorsConceptsPhase II trialCohort 2Cohort 1PI3K pathwayTumor tissueII trialRecurrent glioblastomaBrain penetrationPan-PI3K inhibitor buparlisibPathway inhibitionPathway activationCommon grade 3K pathwayPrimary end pointGreater adverse eventsProgression-free survivalPI3K pathway inhibitionPI3K pathway activationPlasma drug levelsSingle-agent efficacySignificant brain penetrationPI3K inhibitorsMedian PFSOpen labelAdverse events
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
2016
ACTR-12. PHASE I/II STUDY OF SINGLE AGENT IBRUTINIB IN RECURRENT/REFRACTORY PRIMARY (PCNSL) AND SECONDARY CNS LYMPHOMA (SCNSL)
Grommes C, Gavrilovic I, Kaley T, Nolan C, Omuro A, Wolfe J, Pentsova E, Hatzoglou V, Mellinghoff I, DeAngelis L. ACTR-12. PHASE I/II STUDY OF SINGLE AGENT IBRUTINIB IN RECURRENT/REFRACTORY PRIMARY (PCNSL) AND SECONDARY CNS LYMPHOMA (SCNSL). Neuro-Oncology 2016, 18: vi3-vi4. DOI: 10.1093/neuonc/now212.011.Peer-Reviewed Original ResearchSecondary CNS lymphomaCNS lymphomaPhase I/II studyRecurrent/refractory diseaseAggressive primary brain tumorCerebrospinal fluid involvementCNS lymphoma patientsGrade 4 toxicityGrade 3 toxicityEnd-organ functionNormal end-organ functionSingle-agent ibrutinibPrimary brain tumorsPromising clinical responsesB-cell malignanciesCommon toxicitiesEligible patientsFungal encephalitisManageable toxicityMedian PFSMethotrexate regimensPrior therapySCNSL patientsClinical responseII study
2014
Phase 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 PFSPHASE 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
2012
Rituximab, methotrexate (MTX), procarbazine, and vincristine (R-MPV) followed by consolidation high-dose chemotherapy (HDC) and autologous stem-cell transplant (ASCT) for newly diagnosed primary CNS lymphoma (PCNSL).
Omuro A, Correa D, Moskowitz C, Matasar M, DeAngelis L, Kaley T, Gavrilovic I, Nolan C, Pentsova E, Grommes C, Abrey L, Sauter C. Rituximab, methotrexate (MTX), procarbazine, and vincristine (R-MPV) followed by consolidation high-dose chemotherapy (HDC) and autologous stem-cell transplant (ASCT) for newly diagnosed primary CNS lymphoma (PCNSL). Journal Of Clinical Oncology 2012, 30: 2008-2008. DOI: 10.1200/jco.2012.30.15_suppl.2008.Peer-Reviewed Original ResearchAutologous stem cell transplantHigh-dose chemotherapyPrimary CNS lymphomaConsolidation high-dose chemotherapyITT populationR-MPVInduction chemotherapyInduction regimenPrimary endpointYear event-free survivalEffective induction regimenEvent-free survivalPhase II trialStem cell transplantImproved response ratesExcellent disease controlComprehensive neuropsychological evaluationHDC regimenHDC-ASCTMedian EFSYear EFSEarly complicationsMedian PFSCNS lymphomaII trial
2010
Nitrosourea-based chemotherapy for low grade gliomas failing initial treatment with temozolomide
Kaloshi G, Sierra del Rio M, Ducray F, Psimaras D, Idbaih A, Laigle-Donadey F, Taillibert S, Houillier C, Dehais C, Omuro A, Sanson M, Delattre JY, Hoang-Xuan K. Nitrosourea-based chemotherapy for low grade gliomas failing initial treatment with temozolomide. Journal Of Neuro-Oncology 2010, 100: 439-441. PMID: 20464625, DOI: 10.1007/s11060-010-0197-6.Peer-Reviewed Original ResearchConceptsLow-grade gliomasGrade gliomasProgressive low-grade gliomaTerms of PFSContrast enhancementEfficacy of nitrosoureasBetter PFSMedian PFSMedian OSObjective responseSalvage treatmentUpfront therapyMedian ageBetter prognosisInitial treatmentConventional radiotherapyChromosome 1p/19q codeletionNon-enhancing tumorResponse ratePatientsTemozolomidePure oligodendrogliomasPFSGliomasDisappointing results
2007
Primary intraocular lymphoma: an International Primary Central Nervous System Lymphoma Collaborative Group Report
Grimm S, Pulido J, Jahnke K, Schiff D, Hall A, Shenkier T, Siegal T, Doolittle N, Batchelor T, Herrlinger U, Neuwelt E, Laperriere N, Chamberlain M, Blay J, Ferreri A, Omuro A, Thiel E, Abrey L. Primary intraocular lymphoma: an International Primary Central Nervous System Lymphoma Collaborative Group Report. Annals Of Oncology 2007, 18: 1851-1855. PMID: 17804469, DOI: 10.1093/annonc/mdm340.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCentral Nervous System NeoplasmsCombined Modality TherapyConsensusEye NeoplasmsFemaleHIV SeronegativityHumansLymphoma, Non-HodgkinMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisRadiotherapy, AdjuvantRetrospective StudiesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsPrimary intraocular lymphomaOverall survivalMedian timeFocal therapyPrimary central nervous system lymphomaMedian ECOG performance statusCentral nervous system lymphomaTreatment typeECOG performance statusPositive CSF cytologyNervous system lymphomaBrain relapseMedian PFSMedian progressionPIOL patientsUncommon subsetIntraocular lymphomaPerformance statusRelapse patternsRetinal biopsyTreatment toxicityMedian ageSystem lymphomaInitial treatmentCSF cytologyA phase II trial of temozolomide and vinorelbine for patients with recurrent brain metastases
Iwamoto F, Omuro A, Raizer J, Nolan C, Hormigo A, Lassman A, Gavrilovic I, Abrey L. A phase II trial of temozolomide and vinorelbine for patients with recurrent brain metastases. Journal Of Clinical Oncology 2007, 25: 2050-2050. DOI: 10.1200/jco.2007.25.18_suppl.2050.Peer-Reviewed Original ResearchPhase II trialRecurrent brain metastasesObjective radiographic responseBrain metastasesII trialRadiographic responseResponse rateWhole-brain radiation therapyAdequate organ functionBrain metastasis resectionSingle-agent temozolomideGrade 3/4 toxicitiesPhase I trialPhase II componentPopulation of patientsFavorable toxicity profileBlood-brain barrierPrimary tumor siteHead/neckTwo-stage clinical trialAssessable patientsMedian KPSMedian PFSPrior therapyMetastasis resection