自体DC治疗术后的恶性神经胶质瘤

《自体DC治疗术后的恶性神经胶质瘤》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。

1、VaccineTherapyinTreatingYoungPatientsWhoAreUndergoingSurgeryforMalignantGliomaThisstudyhasbeencompleted・FirstReceivedonApril5,2005.LastUpdatedonMay17,2010HistoryofChanqesSponsor:UniversityofCalifornia,LosAngelesCollaborator:NationalCancerInstitute(NCI)Informationprovidedby:Univ

2、ersityofCalifornia,LosAngelesClinicalTrials.govIdentifier:NCT00107185・PurposeRATIONALE:Vaccinesmadefromaperson'swhitebloodcellsandtumorcellsmayhelpthebodybuildaneffectiveimmuneresponsetokilltumorcells.Givingvaccinetherapyaftersurgerymaybeamoreeffectivetreatmentformalignantgliom

3、a.PURPOSE:ThisphaseItrialisstudyingthesideeffectsandbestdoseofvaccinetherapyintreatingyoungpatientswhoareundergoingsurgeryformalignantglioma.ConditionInterventionPhaseBrainandCentralNervousSystemTumorsBiological:therapeuticautologousdendriticcellsProcedure:adjuvanttherapyProced

4、ure:therapeuticconventionalsurgeryPhaseIStudyType:InterventionalStudyDesign:PrimaryPurpose:TreatmentOfficialTitle:PhaseIDoseEscalationStudyofAutologousTumorLysate-PulsedDendriticCellImmunotherapyforMalignantGliomasinPediatricPatientsResourcelinksprovidedbyNLM:MedlinePlusrelated

5、topics:CancerU.S.FDAResourcesFurtherstudydetailsasprovidedbyUniversityofCalifornia,LosAngeles:EstimatedEnrollment:18StudyStartDate:January2005StudyCompletionDate:March2010PrimaryCompletionDate:October2009(Finaldatacollectiondateforprimaryoutcomemeasure)DetailedDescription:OBJEC

6、TIVES:Primary•Determinethedose-limitingtoxicityofadjuvantvaccinationwithautologoustumorlysate-pulseddendriticcellsaftersurgicalresectioninpediatricpatientswithmalignantglioma.•Determinethemaximumtolerateddoseofthisvaccineinthesepatients.Secondary•Determine,preliminarily,thesurv

7、ivalofpatientstreatedwiththisvaccine.•Determine,preliminarily,thetimetotumorprogressioninpatientstreatedwiththisvaccine.•Determinecellularimmuneresponseinpatientstreatedwiththisvaccine.•Determineage-dependentdifferencesinresponsetothisvaccine,intermsofimmunocompetenee,inthesepa

8、tients.OUTLINE:Thisisadose-escalationstudy.Patientsund