2023
Multicenter 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
2020
CTNI-50. NEUROCOGNITIVE FUNCTION (NCF) OF THE PHOTON COHORT IN NRG-BN001
Wefel J, DeMora L, Gondi V, Tsien C, Chenevert T, Gilbert M, Omuro A, Cao Y, Srinivasan A, Rogers L, Shi W, Nedzi L, Chan M, Suh J, Battiste J, Mishra M, Shivnani A, Movsas B, Mehta M. CTNI-50. NEUROCOGNITIVE FUNCTION (NCF) OF THE PHOTON COHORT IN NRG-BN001. Neuro-Oncology 2020, 22: ii53-ii54. PMCID: PMC7651205, DOI: 10.1093/neuonc/noaa215.216.Peer-Reviewed Original ResearchNeurocognitive functionNCF testsSD-RTCycle 3Ongoing randomized phase II trialRandomized phase II trialNon-significant timeSecondary endpoint analysisPhase II trialMixed effects longitudinal modelsTreatment effect interactionEvaluable patientsNCF outcomesPhoton cohortsEligible patientsII trialOverall survivalPatient refusalRadiation therapyGroup 2Common reasonGroup 1Arm differencesPatientsEffects longitudinal models
2015
Phase I dose-escalation study of the PI3K/mTOR inhibitor voxtalisib (SAR245409, XL765) plus temozolomide with or without radiotherapy in patients with high-grade glioma
Wen PY, Omuro A, Ahluwalia MS, Fathallah-Shaykh HM, Mohile N, Lager JJ, Laird AD, Tang J, Jiang J, Egile C, Cloughesy TF. Phase I dose-escalation study of the PI3K/mTOR inhibitor voxtalisib (SAR245409, XL765) plus temozolomide with or without radiotherapy in patients with high-grade glioma. Neuro-Oncology 2015, 17: 1275-1283. PMID: 26019185, PMCID: PMC4588757, DOI: 10.1093/neuonc/nov083.Peer-Reviewed Original ResearchConceptsHigh-grade gliomasAdverse eventsRadiation therapySkin biopsiesPhase I dose-escalation studyTreatment-related adverse eventsI dose-escalation studyPI3K/mTOR pathway inhibitionTreatment-related gradeDose-escalation studyDose-escalation designFavorable safety profileMTOR pathway inhibitionEvaluable patientsStable diseasePartial responsePharmacodynamic effectsPlatelet countRapamycin inhibitorsSafety profilePreliminary efficacyTumor responsePlasma pharmacokineticsVoxtalisibPatients
2014
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
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
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
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
2010
Up-front temozolomide in elderly patients with anaplastic oligodendroglioma and oligoastrocytoma
Ducray F, Sierra del Rio M, Carpentier C, Psimaras D, Idbaih A, Dehais C, Kaloshi G, Mokhtari K, Taillibert S, Laigle-Donadey F, Omuro A, Sanson M, Delattre JY, Hoang-Xuan K. Up-front temozolomide in elderly patients with anaplastic oligodendroglioma and oligoastrocytoma. Journal Of Neuro-Oncology 2010, 101: 457-462. PMID: 20556480, DOI: 10.1007/s11060-010-0264-z.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic Agents, AlkylatingBrain NeoplasmsDacarbazineDNA MethylationDNA Modification MethylasesDNA Repair EnzymesDNA, NeoplasmFemaleFollow-Up StudiesHumansMaleOligodendrogliomaPolymerase Chain ReactionPromoter Regions, GeneticRetrospective StudiesSurvival RateTemozolomideTreatment OutcomeTumor Suppressor ProteinsConceptsProgression-free survivalAnaplastic oligodendroglial tumorsElderly patientsOverall survivalFront chemotherapyPartial responseMedian progression-free survivalLonger progression-free survivalInitial radiation therapyLonger overall survivalDuration of responseRate of respondersO6-methylguanine-DNA methyltransferase (MGMT) promoter methylationMethyltransferase promoter methylationEvaluable patientsStable diseaseConsecutive patientsConventional dosesRetrospective studyOptimal treatmentAnaplastic oligodendrogliomaRadiation therapyPatientsOligodendroglial tumorsTumor progression