PHASE II/III CLINICAL TRIALS OF ANTICANCER AGENTS

本次发行提供了第二阶段和第三阶段的单一机构方案 抗癌药物的开发。德克萨斯大学医学博士安德森 由医生领导的针对特定疾病的临床癌症小组组成 他们在抗肿瘤药物的开发方面有广泛的背景。 这些临床团队包括参与治疗的医生。 黑色素瘤、肉瘤、乳房、妇科、胃肠、肺、头 以及颈部、泌尿生殖系统和神经系统的恶性肿瘤。专科医生 团队提供设计骨髓临床试验的专业知识 移植以及白血病和淋巴瘤的治疗。至 了解正在开发的抗癌药物的基础科学，请访问 机构、实验室相关研究团队密切互动 与上述临床调查人员联系。相关实验室的面积 研究内容包括分析生物化学、 药代动力学/药效学研究、免疫药理学、细胞 药理学，细胞毒性/致死性，多胺合成和 抑制力。临床癌症和实验室相关研究小组 由数据管理/质量控制团队提供支持，该团队包括 临床试验支持核心(临床试验管理、数据 管理和质量保证、数据管理支持和科学=c 审查委员会)、生物统计学和研究药房(临床 材料搬运和放射性药品)。通过协作 以上三个团队的互动，新的抗癌药物已经 经过一期测试后，得到进一步发展。该提案提供了一个 确定选定代理在以下方面的活性谱的机制 多种人类癌症，确立了新制剂的作用(或 类似物)，单独或组合，并将这一角色与标准 治疗。此外，HIGH的第二阶段/第三阶段发展的方法 使用集落刺激因子、外周血干细胞或 提供自体骨髓支持。

This offering provides a single-institution proposal for Phase II and III development of anti-cancer agents. The University of Texas M.D. Anderson is comprised of disease-specific clinical cancer teams lead by physicians who have extensive backgrounds in the development of antineoplastic agents. These clinical teams include physicians involved in the treatment of melanomas, sarcomas, breast, gynecological, gastrointestinal, lung, head and neck, genitourinary, and neurological malignancies. Specific physician teams provide expertise in designing clinical trials in bone marrow transplantation and in the treatment of leukemias and lymphomas. To understand the basic science of anti-cancer agents under development at athe institution, laboratory correlative studies teams interact closely with the above clinical investigators. Areas of correlative laboratory investigation include analytical biochemistry, pharmacokinetic/pharmacodynamic studies, immunopharmacology, cellular pharmacology, cellular toxicity/lethality, and polyamine synthesis and inhibition. The clinical cancer and laboratory correlative studies teams are supported by a data management/quality control team which is comprised of a clinical trials support core (clinical trials administration, data management and quality assurance, data management support, and scientific=c review committee), biostatistics, and a research pharmacy (clinical materials handling and radiopharmaceuticals). Through the collaborative interaction of the above three teams, new anticancer agents which have undergone Phase I testing are further developed. The proposal provides a mechanism to determine the spectrum of activity of selected agents across a variety of human cancers, establish the role of new agents (or analogues), alone or in combination, and compare this role with standard therapies. In addition, approaches to Phase II/III development of high dose therapy using colony-stimulating factors, peripheral stem cells, or autologous bone marrow support are provided.