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

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 摘要 我们打算测试两种同种异体神经母细胞瘤细胞系疫苗组合的安全性、免疫学和临床疗效，其中一种疫苗已经过基因改造，可分泌IL-2和淋巴动蛋白的细胞因子/趋化因子组合，用于接受单一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患者的化疗。 该方案将作为一项I/IIa期研究进行，以评估将先前未研究的、未经修饰的辐射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-IL2/Lptn作为疫苗给被诊断为高危神经母细胞瘤的患者的安全性和毒性。

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.