PHASE I STUDY OF ERBITUX (CETUXIMAB) IN PED SUBJ WITH SOLID TUMORS CA225-085

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 2001年，美国0-19岁儿童的癌症发病率为每10万人中有16.5人罹患癌症。一般来说，实体瘤约占儿童癌症病例的30%。这些肿瘤在对许多化疗药物的反应性方面是独一无二的。然而，儿童实体瘤患者的预后非常差，而这些实体瘤对以往的化疗是无效的。伊立替康已经在人群中进行了广泛的研究，并显示出在一系列剂量和方案中的活性，毒性可控。尽管西妥昔单抗尚未在儿科人群中进行研究，但基于其在成人中的良好安全性，预计不会出现严重毒性。此外，考虑到它在各种成人肿瘤中的有效性，它很可能也会在一些儿科恶性肿瘤中看到活性。因此，考虑到这些患者的预后很差，预计在患有难治性实体肿瘤的儿科患者中研究这种联合治疗的好处将远远大于风险。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In the United States, in 2001, the incidence of cancer was 16.5 per 100,000 children aged 0 - 19 years. In general, solid tumors account for approximately 30% of cases of childhood cancers. These tumors are unique with the respect to their responsiveness to many chemotherapeutic agents. However, the prognosis is very poor for pediatric patients with solid tumors which are refractory to previous chemotherapy. Irinotecan has been studied extensively in the population and has demonstrated activity across a range of doses and regimens with manageable toxicities. Although cetuximab has not been studied in the pediatric population, based on its favorable safety profile in adults, no severe toxicities are expected. In addition, given its demonstrated efficacy in a variety of adult tumors, it is likely that activity will be seen in some pediatric malignancies as well. Thus, given the poor prognosis of these patients, it is expected that the benefit of studying this combination in pediatric patients with refractory solid tumors will be far greater than the risks.