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
1996
A phase III randomized prospective trial of external beam radiotherapy, mitomycin C, carmustine, and 6-mercaptopurine for the treatment of adults with anaplastic glioma of the brain
Halperin E, Herndon J, Schold S, Brown M, Vick N, Cairncross J, Macdonald D, Gaspar L, Fischer B, Dropcho E, Rosenfeld S, Morowitz R, Piepmeier J, Hait W, Byrne T, Salter M, Imperato J, Khandekar J, Paleologos N, Burger P, Bentel G, Friedman A. A phase III randomized prospective trial of external beam radiotherapy, mitomycin C, carmustine, and 6-mercaptopurine for the treatment of adults with anaplastic glioma of the brain. International Journal Of Radiation Oncology • Biology • Physics 1996, 34: 793-802. PMID: 8598355, DOI: 10.1016/0360-3016(95)02025-x.Peer-Reviewed Original ResearchConceptsExternal beam radiotherapyKarnofsky performance statusMedian survivalSurvival benefitERT groupAnaplastic gliomasBeam radiotherapyMitomycin CVs. 11.4 monthsProportion of patientsSignificant survival benefitPossible survival benefitTreatment of adultsYears of ageBCNU groupPerformance statusProspective trialHistologic diagnosisMalignant gliomasMito groupStereotactic biopsyPatientsGreater riskFourth weekThird day