ADVL0911 A PHASE 1 DOSE ESCALATION STUDY OF SENECA

ADVL0911 SENECA 的 1 期剂量递增研究

• 批准号: 8356732
• 负责人: PATRICK THOMPSON
• 金额: $ 0.47万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356732
• 关键词: Adrenocortical carcinoma; Adult; Carcinoid Tumor; Child; Clinical; Clinical Research; Dose; Drug Kinetics; Ewings sarcoma; Family Picornaviridae; Funding; Grant; Hour; In Vitro; Infusion procedures; Kilogram; National Center for Research Resources; Nephroblastoma; Neuroblastoma; Neurosecretory Systems; Oncolytic; Patients; Phase; Principal Investigator; Property; RNA Viruses; Refractory; Relapse; Research; Research Infrastructure; Resources; Retinoblastoma; Rhabdomyosarcoma; Source; Toxic effect; United States National Institutes of Health; Viral; Virus; cohort; cost; in vivo; killings; neoplastic cell; particle; phase 1 study; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Seneca Valley Virus (SVV-001) is an oncolytic RNA virus classified within the family Picornaviridae that has been shown to be selective and potent toward killing tumor cells having one or more neuroendocrine properties in both in vitro and in vivo studies. This phase I study will evaluate the toxicities, viral clearance (pharmacokinetics), and clinical activity of SVV-001 in children with relapsed/refractory neuroblastoma, rhabdomyosarcoma, Ewing Family of tumors, or rare tumors with neuroendocrine features (Wilms- tumor, retinoblastoma, adrenocortical carcinoma or carcinoid tumors). Cohorts of three to six patients will receive a single 1 hour infusion of SVV-001 at a starting dose of 1x109 viral particles (vp) per kilogram (vp/kg) (2-logs below the adult starting dose). The starting dose will be escalated by 1-log increments in additional cohorts of three to six patients until the maximum tolerable dose is determined or 1x1012 vp/kg is reached in dose level 4.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 Seneca Valley病毒（SVV-001）是一种分类在小核糖核酸病毒科中的溶瘤RNA病毒，其在体外和体内研究中都显示出对杀死具有一种或多种神经内分泌特性的肿瘤细胞具有选择性和效力。这项I期研究将评估SVV-001在患有复发性/难治性神经母细胞瘤、横纹肌肉瘤、尤文家族肿瘤或伴有神经内分泌肿瘤的罕见肿瘤的儿童中的毒性、病毒清除（药代动力学）和临床活性。 特征（肾母细胞瘤、视网膜母细胞瘤、肾上腺皮质癌或类癌）。三至六名患者的组群将接受SVV-001的单次1小时输注，起始剂量为每千克1 × 109个病毒颗粒（vp）（vp/kg）（低于成人起始剂量2 log）。在3 - 6例患者的额外队列中，起始剂量将以1-log增量递增，直至确定最大耐受剂量或1x 1012 在剂量水平4中达到vp/kg。