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 factorMethotrexate 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
2013
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.
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