2010
Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma†
Kunwar S, Chang S, Westphal M, Vogelbaum M, Sampson J, Barnett G, Shaffrey M, Ram Z, Piepmeier J, Prados M, Croteau D, Pedain C, Leland P, Husain SR, Joshi BH, Puri RK, Group F. Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma†. Neuro-Oncology 2010, 12: 871-881. PMID: 20511192, PMCID: PMC2940677, DOI: 10.1093/neuonc/nop054.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntineoplastic AgentsBrain NeoplasmsCarmustineCatheters, IndwellingConvectionDecanoic AcidsDrug Administration RoutesExotoxinsFemaleGlioblastomaHumansInterleukin-13Kaplan-Meier EstimateMagnetic Resonance ImagingMaleMiddle AgedNeoplasm Recurrence, LocalPolyestersRecombinant Fusion ProteinsYoung AdultConceptsConvection-enhanced deliveryCintredekin besudotoxGliadel wafersMedian survivalTumor resectionGlioblastoma multiformeEfficacy-evaluable populationAdverse event profileHealth-related qualityPhase III evaluationTime of randomizationEvaluable populationTertiary endpointsPrimary endpointAdult patientsBaseline characteristicsFirst recurrenceOverall survivalPulmonary embolismActive comparatorTreatment armsIL13-PE38QQRIntraparenchymal catheterSurvival differencesGBM patients
2007
Direct Intracerebral Delivery of Cintredekin Besudotox (IL13-PE38QQR) in Recurrent Malignant Glioma: A Report by the Cintredekin Besudotox Intraparenchymal Study Group
Kunwar S, Prados MD, Chang SM, Berger MS, Lang FF, Piepmeier JM, Sampson JH, Ram Z, Gutin PH, Gibbons RD, Aldape KD, Croteau DJ, Sherman JW, Puri RK. Direct Intracerebral Delivery of Cintredekin Besudotox (IL13-PE38QQR) in Recurrent Malignant Glioma: A Report by the Cintredekin Besudotox Intraparenchymal Study Group. Journal Of Clinical Oncology 2007, 25: 837-844. PMID: 17327604, DOI: 10.1200/jco.2006.08.1117.Peer-Reviewed Original ResearchConceptsConvection-enhanced deliveryIntracerebral convection-enhanced deliveryCintredekin besudotoxRecurrent malignant gliomaMalignant gliomasGlioblastoma multiformeMedian survivalCatheter placementTumor resectionInfusion durationProcedure-related adverse eventsFavorable risk-benefit profilePhase I clinical studyBetter drug distributionDirect intracerebral deliveryOptimal drug distributionOverall median survivalPortion of patientsRisk-benefit profileDevastating brain tumorDrug distributionAdverse eventsHigh tissue concentrationsIntracerebral deliveryTumor necrosis
1996
Variations in the natural history and survival of patients with supratentorial low-grade astrocytomas.
Piepmeier J, Susan Christopher R, Spencer D, Byrne T, Kim J, Knisel J, Lacy J, Tsukerman L, Makuch R. Variations in the natural history and survival of patients with supratentorial low-grade astrocytomas. Neurosurgery 1996, 38: 872-8; discussion 878-9. PMID: 8727811, DOI: 10.1097/00006123-199605000-00002.Peer-Reviewed Original ResearchConceptsLow-grade astrocytomasGross total resectionChronic epilepsySupratentorial low-grade astrocytomasNatural historyGross total tumor resectionImmediate postoperative radiotherapyExtent of surgerySurvival of patientsTen-year survivalPopulation of patientsUse of radiotherapyRisk of recurrenceHigh-grade lesionsLength of survivalMore malignant tumorsTypes of symptomsAggressive surgeryPostoperative radiotherapyPreoperative symptomsConsecutive patientsBetter prognosisTumor recurrenceTumor resectionMalignant tumors