Clinical Research Support for the CCR

支持癌症中心的临床服务计划（CSP）实验室 研究（CCR）如下所示。CCR临床支持的专门支持 实验室（CSL）。CSL提供临床监测、流式细胞术和淋巴因子检测 约33项CCR临床试验。CSL还提供临床样本处理， 在位于NIH临床实验室的实验室空间中为CCR临床药理学核心提供测试支持 中心在贝塞斯达，马里兰州。人类癌症免疫毒素治疗检测支持和开发 实验室该实验室为CCR分子生物学实验室提供专门支持 (Dr.伊拉帕斯坦，主任），用于制药商发起的研究和临床试验，重点是 基因工程免疫毒素目前，有3种免疫毒素正在进行临床评价： 1)LMB 2用于某些淋巴瘤，2）BL 22用于某些淋巴瘤和成人毛细胞白血病 和儿科患者，和3）HA 22，其是一种正在研究的高亲和力免疫毒素， 替换BL 22。细胞介导免疫实验室（LCMI）LCMI提供专门的支持 符合NCI疫苗工作组监督委员会的要求。主 该实验室的使命是提供尖端的，临床验证的免疫学 广泛适用于NCI研究者的检测，以解决临床和基础 研究问题。迄今为止，已经验证了7种不同的免疫学测定用于临床 使用. LCMI的另一项使命是与疫苗工作组协调， 集团监督委员会，新的免疫测定，可以提供更精确， 在临床环境中分析细胞介导免疫的不同方面的准确手段。 支持NCI实验治疗计划NCI实验治疗（NExT） 该计划是癌症治疗和诊断部门（DCTD）与 癌症研究中心（CCR）。旨在简化开发和测试， 有希望的新抗癌药物，并加快其从实验室到床边的交付， 该方案利用了两个组织的优势。DCTD长期以来 药物开发的专业知识以及与制药和生物技术的关系 公司，而CCR是世界闻名的综合方法，翻译基本 将科学发现转化为临床应用该计划还旨在提供 NCI研究人员与外部学术界和工业界合作的机会 科学家NExT计划侧重于在药物开发早期评估药物作用 过程这些早期试验的基本目标是促进快速初始化 新的抗癌治疗剂和显像剂在人类中的应用评价 和资源，以一个大规模的，全面的发展计划。国家临床目标确认 实验室（NCTVL）。该国家实验室是应国家卫生部的要求于2006财政年度建立的。 DCTD是DCTD和CCR之间的合作，旨在解决机械差距 在肿瘤药物开发中，由于固有的困难， 确定治疗性干预对其假定作用位点的影响， 患者该实验室作为阐明新靶组织的α位点 特别适用于人类癌症早期和I/II期临床的方法 CCR发育治疗诊所的试验，证实了 小分子抗癌剂对感兴趣的特定信号转导途径的影响 在临床前开发期间观察到的人类。国家临床医学中心的使命 目标验证实验室将执行经验证的检测程序，以检测肿瘤或 分子靶向治疗效果的替代组织。实验室评估药物 使用经验证的靶点测定对CCR内治疗患者的分子靶点的影响， 其中许多将从药效学试验开发中转移， 人体毒理学和药理学实验室实施方案 (DCTD/SAIC-Frederick，Inc.）。除了为CCR内部调查人员提供支持外， NCTVL还为来自国家癌症研究所资助的 缺乏资源或专业知识的校外研究人员在现场进行此类测定。 合成化学实验室。合成化学实验室成立于 2007年，为DCTD的药物发现和开发工作提供化学支持 开发治疗学项目（DTP）和联合开发批准的项目 DCTD-CCR委员会。为此，实验室将重点开展活动，以领导 优化是新药发现和开发的重要组成部分。小说 将开发合成方法，以根据指定的先导化合物创造新的类似物 化合物以改善药物特性， 方式：活性、选择性、亲脂性、生物利用度、稳定性和ADME/PK。实验室 将开发新的相关综合方法，供更广泛的NCI校外应用 社区

Clinical Services Program (CSP) laboratories that support the Center for Cancer Research (CCR) are highlighted below. Dedicated Support for the CCR Clinical Support Laboratory (CSL). The CSL provides clinical monitoring, flow cytometry, and lymphokine testing for approximately 33 CCR clinical trials. The CSL also provides clinical sample processing and testing support to the CCR Clinical Pharmacology Core in lab space located at the NIH Clinical Center in Bethesda, Maryland. Human Cancer Immunotoxin Therapy Assay Support and Development Laboratory. This laboratory provides dedicated support to CCRs Laboratory of Molecular Biology (Dr. Ira Pastan, Chief), for investigator-initiated studies and clinical trials focusing on genetically engineered immunotoxins. Currently, 3 immunotoxins are being evaluated clinically: 1) LMB2 for certain lymphomas, 2) BL22 for certain lymphomas and hairy cell leukemia in adult and pediatric patients, and 3) HA22, which is a high-affinity immunotoxin under study to replace BL22. Laboratory of Cell-Mediated Immunity (LCMI). The LCMI provides dedicated support to meet the requirements of the NCI Vaccine Working Group Oversight Committee. The primary mission of this laboratory is to provide cutting-edge, clinically validated immunological assays that are broadly applicable to NCI investigators to address both clinical and basic research questions. To date, 7 different immunological assays have been validated for clinical use. A secondary mission of the LCMI is to develop, in coordination with the Vaccine Working Group Oversight Committee, new immunological assays that can provide a more precise and accurate means of analyzing different aspects of cell-mediated immunity in clinical settings. Support for the NCI Experimental Therapeutics Program The NCI Experimental Therapeutics (NExT) Program is a partnership between the Division of Cancer Treatment and Diagnosis (DCTD) and the Center for Cancer Research (CCR). Aimed at streamlining the development and testing of promising new anticancer drugs and expediting their delivery from the bench to the bedside, the program capitalizes on the strengths of both organizations. The DCTD has longstanding expertise in drug development and relationships with pharmaceutical and biotechnology companies, while the CCR is world renowned for its comprehensive approach to translating basic science discoveries into clinical applications. The program is also designed to provide opportunities for NCI researchers to collaborate with external academic and industry scientists. The NExT Program focuses on assessing drug action early in the drug-development process. The fundamental goal of these early-phase trials is to facilitate fast initial evaluation of new anticancer therapeutic and imaging agents in humans before committing time and resources to a large-scale, full developmental plan. National Clinical Target Validation Laboratory (NCTVL). This national laboratory was established in FY06 at the request of the DCTD and is a collaboration between the DCTD and CCR aimed at addressing the mechanistic gap in oncologic drug development that frequently occurs due to the difficulties inherent in determining the effect of a therapeutic intervention on its putative site of action in patients. The laboratory serves as an alpha site for the elucidation of novel target tissue methodologies specifically applicable to human cancer early-phase and Phase I/II clinical trials in the CCR Developmental Therapeutics Clinic, confirming the therapeutic effects of small molecule anticancer agents on specific signal transduction pathways of interest in humans that were observed during preclinical development. The mission of the National Clinical Target Validation Laboratory is to conduct validated assay procedures to test tumor or surrogate tissues for effects of molecularly targeted therapies. The laboratory assesses drug effects on molecular targets in patients treated within CCR using validated target assays, many of which will be transferred from the pharmacodynamic assay development and implementation program of the Laboratory of Human Toxicology and Pharmacology (DCTD/SAIC-Frederick, Inc). In addition to providing support for CCR intramural investigators, the NCTVL also provides target validation assays for patient samples from NCI-funded extramural investigators lacking the resources or expertise to conduct such assays on site. Laboratory of Synthetic Chemistry. The Laboratory of Synthetic Chemistry was established in 2007 to provide chemistry support to the drug discovery and development efforts of the DCTDs Developmental Therapeutics Program (DTP) and the projects approved by the Joint Development Committee of DCTD-CCR. Towards this end, the laboratory will focus its activities to lead optimization, an essential and integral part of new drug discovery and development. Novel synthetic methodologies will be developed to create new analogs based on the assigned lead compounds to improve pharmaceutical profiles by addressing the following in an iterative manner: activity, selectivity, lipophilicity, bioavailability, stability, and ADME/PK. The lab will develop new relevant synthesis methodologies for applications by the wider NCI extramural community.