A PHASE I/II STUDY OF IMMUNIZATION WITH LYMPHOTACTIN AND INTERLEUKIN 2 GENE MODI

淋巴细胞趋化素和白细胞介素 2 基因 MODI 免疫的 I/II 期研究

• 批准号: 8356698
• 负责人: CHRYSTAL U LOUIS
• 金额: $ 0.55万
• 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/8356698
• 关键词: Allogenic; Autologous; Cell Line; Clinical Research; Consolidation Therapy; Diagnosis; Dose; Funding; Gene-Modified; Grant; IL2 gene; Immunization; Immunologics; Interleukin-2; National Center for Research Resources; Neuroblastoma; Newly Diagnosed; Patients; Phase; Principal Investigator; Protocols documentation; Research; Research Infrastructure; Resources; Safety; Source; Stem cells; Toxic effect; Tumor Cell Line; United States National Institutes of Health; Vaccines; chemokine; chemotherapy; clinical efficacy; cost; cytokine; high risk; neuroblastoma cell; safety testing

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. ABSTRACT We intend to test the safety, and immunologic and clinical efficacy of a combination of 2 allogeneic neuroblastoma tumor cell line vaccines, one of which has been genetically modified to secrete the cytokine/chemokine combination of IL-2 and lymphotactin, in patients undergoing chemotherapy for newly diagnosed, high risk neuroblastoma who receive single autologous stem cell rescue as consolidation therapy. This protocol will be carried out as a Phase I/IIa study to evaluate the safety and toxicity of adding a previously unstudied, unmodified, irradiated neuroblastoma cell line (SKNLP) to a studied, safe dose of a gene modified, IL-2/Lptn secreting neuroblastoma cell line SJNB-JF-IL2/Lptn to be given as a vaccine to patients diagnosed with high risk neuroblastoma.

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。 摘要 我们打算在接受单次自体干细胞拯救作为巩固治疗的新诊断高风险神经母细胞瘤化疗患者中，测试2种同种异体神经母细胞瘤肿瘤细胞系疫苗组合的安全性、免疫学和临床疗效，其中一种疫苗经过基因修饰，可分泌IL-2和趋化因子组合。 本方案将作为I/IIa期研究进行，以评价将先前未研究的、未修饰的、经辐照的神经母细胞瘤细胞系（SKNLP）添加到研究的、安全剂量的基因修饰的、分泌IL-2/Lptn的神经母细胞瘤细胞系SJNB-JF-IL 2/Lptn中的安全性和毒性，该细胞系将作为疫苗给予诊断为高风险神经母细胞瘤的患者。