PEDIATRIC PRECLINICAL TESTING PROGRAM

该合同通过在儿童癌症临床前模型中系统地测试药物，为癌症治疗和诊断部门（DCTD）的癌症治疗评估计划（CTEP）提供支持。对一组儿科临床前模型进行系统评价的目的是优先考虑用于癌症儿童研究的新药。该合同提供临床前疗效和药代动力学数据，以与测试药物的临床结果相关联。 该合同每年测试10-12种药物或药物组合，针对最常见于儿童的儿童癌症的一组临床前模型。为了校准儿科临床前小组，一些测试的药物是标准化疗药物，其对特定肿瘤类型的临床活性是已知的。对于测试的药剂，进行药代动力学研究以确定与抗肿瘤活性相关的血清药物水平和全身暴露。从临床前测试程序获得的结果与临床活性和受试药物的药代动力学特征相关，以评估该程序的预测能力。该项目的目标是通过从可能用于癌症儿童评估的肿瘤药物中确定最有效的药物进行临床试验，提高癌症儿童的存活率。

The contract provides support to the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD) by systematically testing agents in childhood cancer preclinical models. The purpose of having a systematic evaluation of a panel of pediatric preclinical models is to prioritize new agents for study in children with cancer. The contract provides preclinical efficacy and pharmacokinetic data to correlate with clinical findings for tested agents. The contract tests 10-12 agents or combinations of agents per year against a panel of preclinical models of the childhood cancers that occur most commonly in children. In order to calibrate the pediatric preclinical panel, some of the agents tested are standard chemotherapy agents for which clinical activity against specific tumor types is known. For agents tested, pharmacokinetic studies are performed to determine the serum drug levels and systemic exposures associated with antitumor activity. Results obtained from the preclinical testing program are correlated with the clinical activity and with the pharmacokinetic profile of the tested agents to assess the predictive capabilities of the program. The project objective is to improve survival for children with cancer by identifying for clinical testing the most effective agents from among the universe of oncologic agents potentially available for evaluation in children with cancer.