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

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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.