Molecular Clinical Trians

在过去的40年里，SJCRH已经 保持高生产率和 杰出的记录在 新的治疗方法的发展 儿童癌症(图1)。这个 这一持续的成功 努力是通过行为来实现的 创新的早期临床试验 通过临床和实验室的合作 癌症中的研究小组 中心。从历史上看，这些临床试验 都专注于药物动力学 性质、临床疗效和毒性 毒品，因为大多数人被认为 通过非特异性细胞毒发挥作用 机械装置。的最新进展 对癌症生物学的认识 导致了药物的发展 以体内的特定分子为靶标 癌细胞，例如酪氨酸抑制剂 激活剂。因此，在过去的5年里 年数占临床总人数比例 在癌症中进行的试验 以测试分子为目标中心 治疗方法增加到了 50%和75%(图1)。要正确评价这类新药的抗癌性能，需要 药物靶标在患者组织中的表达和活性的评估以及药物的测量 药代动力学、疗效和毒性。因此，要确保SJCRH始终走在抗癌的前沿 药物开发它已经成立了MCTC，它提供：关于纳入分子的专家建议 临床试验中药物靶标表达和活性的分析.有效和适当收集的系统 和临床样本的处理；用于对药物靶标进行敏感和具体分析的专家实验室设施 这些临床材料；并支持适当分析和解释 这些化验结果。通过这种方式，MCTC共享资源直接响应 国家癌症研究所(NCI)临床试验委员会(对临床试验计划审查的回应 Armitage Committee)，以及癌症协会为I期和II期试验设计提供的模板的第7节 NCI的治疗评估计划(CTEP)。

Over the last 40 years SJCRH has maintained a highly-productive and distinguished record in the development of new treatments of childhood cancers (Figure 1). The continued success of this ongoing effort is made possible by the conduct of innovative early phase clinical trials by collaborating clinical and laboratory research groups within the Cancer Center. Historically, these clinical trials have focused on the pharmacokinetic properties, clinical efficacy and toxicity of drugs, since most were believed to act through non-specific cytotoxic mechanisms. Recent advances in understanding of the biology of cancer have led to the development of drugs that target specific molecules within cancer cells, e.g. inhibitors of tyrosine kinases. Therefore, over the last 5 years the proportion of the clinical trials conducted within the Cancer Center that test molecular targeted therapies has increased to between 50 and 75% (Figure 1). The proper evaluation of the anticancer properties of this new class of drugs requires assessment of the expression and activity of the drug target within patient tissues alongside measures of drug pharmacokinetics, efficacy and toxicity. Therefore, to ensure that SJCRH remains at the forefront of anticancer drug development it has established the MCTC that provides: expert advice on the incorporation of molecular assays of drug target expression and activity within clinical trials; systems for the efficient and proper collection and handling of clinical samples; expert laboratory facilities for sensitive and specific analysis of drug targets in these clinical materials; and support for the appropriate analysis and interpretation of all data generated by these assays. In this manner the MCTC Shared Resource responds directly to recommendations made by the National Cancer Institute's (NCI) Clinical Trials Committee (response to the Clinical Trials Program Review Armitage Committee), and to section 7 of templates provided for both Phase I and II trial design by the Cancer Therapeutics Evaluation Program (CTEP) at NCI.