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

爱必妥（西妥昔单抗）在患有实体瘤 CA225-085 的 PED 受试者中的 I 期研究

• 批准号: 7605502
• 负责人: STEPHEN Patrick HUNGER
• 金额: $ 0.91万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-23 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605502
• 关键词: Accounting; Adult; Cetuximab; Child; Childhood; Computer Retrieval of Information on Scientific Projects Database; Dose; Erbitux; Funding; Grant; Incidence; Institution; Malignant Childhood Neoplasm; Malignant Neoplasms; Patients; Phase I Clinical Trials; Population; Range; Refractory; Research; Research Personnel; Resources; Risk; Safety; Solid Neoplasm; Source; Toxic effect; Treatment Protocols; United States; United States National Institutes of Health; aged; base; chemotherapeutic agent; chemotherapy; irinotecan; outcome forecast; tumor

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 在美国，2001年，癌症的发病率为每10万名0-19岁儿童。 通常，实体瘤约占儿童癌症病例的30％。 这些肿瘤在对许多化学治疗剂的反应性方面是独一无二的。 但是，对于患有固体瘤的小儿患者而言，对先前化学疗法难治性的儿科患者的预后非常差。 伊立替康（Irinotecan）在人群中进行了广泛的研究，并在各种剂量和方案中都表现出了可管理毒性的活性。 尽管尚未在儿科人群中研究西妥昔单抗，但根据其在成年人的有利安全性，但预计不会进行严重的毒性。 此外，鉴于其在各种成年肿瘤中具有疗效，因此在某些小儿恶性肿瘤中也可能会出现活动。 因此，鉴于这些患者的预后不佳，预计研究这种组合在儿科固体瘤患者中的好处将远大于风险。