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IGF::OT::IGF VADIS TRIAL: PHASE II TRIAL OF E75 PEPTIDE VACCINE IN WOMEN WITH DCIS OF THE BREAST

IGF::OT::IGF VADIS TRIAL: PHASE II TRIAL OF E75 PEPTIDE VACCINE IN WOMEN WITH DCIS OF THE BREAST
IGF::OT::IGF VADIS 试验：E75 肽疫苗用于患有乳腺癌的女性的 II 期试验
批准号：
10017779
负责人：
POWEL BROWN
金额：
$5.82万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
项目状态：
已结题
起止时间：
2015-09-15 至 2020-09-14
来源：
https://reporter.nih.gov/project-details/10017779
关键词：
Activities of Daily LivingAdverse eventApoptosisBiological AssayBiopsyBreastCASP3 geneCD3 AntigensCD8-Positive T-LymphocytesCD8B1 geneCell ProliferationCellsCleaved cellClinical TrialsCytotoxic T-LymphocytesERBB2 geneEligibility DeterminationEpitope spreadingExcisionFrequenciesGranulocyte-Macrophage Colony-Stimulating FactorHLA-A2 AntigenHistologicImmune responseImmunohistochemistryInfiltrationLymphocyteMulticenter StudiesNoninfiltrating Intraductal CarcinomaOperative Surgical ProceduresParticipantPatientsPeptide VaccinesPhaseRandomizedSlideSpecimenStainsT cell responseToxic effectTumor AntigensVaccinatedVaccinationVaccinesWomanarmcytokineimmunogenicityphase II trialresponse

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中文摘要
翻译
拟议的临床试验将评价E75肽疫苗与单独GM-CSF相比在导管原位癌妇女中的免疫原性。 这是一项针对组织学证实的导管原位癌女性的术前/术后IIb期、随机、多中心研究。符合所有其他合格性标准的HLA-A2+受试者将随机接受NeuVaxTM（nelipepimut-S; 1000 μg E75和250 μg GM-CSF）或GM-CSF单药治疗。随机分配至nelipepimut-S + GM-CSF组的患者将接受三次nelipepimut-S（1000 μg）和GM-CSF（250 μg）的疫苗接种，在手术前间隔两周皮内接种，并在手术后间隔1个月接种三次，共接种六次。
英文摘要
The proposed clinical trial will evaluate immunogenicity of E75 peptide vaccine in women with ductal carcinoma in situ in comparison to GM-CSF alone. It is a pre-surgical/ post-surgical phase IIb, randomized, multi-center study for women with histologically confirm ductal carcinoma in situ. HLA-A2+ participants who meet all other eligibility criteria will be randomized to receive NeuVaxTM (nelipepimut-S; 1000 μg of E75 and 250 μg of GM-CSF) or GM-CSF alone. Patients randomized to the nelipepimut-S + GM-CSF arm will receive three vaccinations of nelipepimut-S (1000 μg) and GM-CSF (250 μg) administered intradermally two weeks apart prior to surgery, and three vaccinations 1 month apart post surgery for six total vaccinations.
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