Protocol-Specific Research Support

特定于协议的研究支持

• 批准号: 7714441
• 负责人: ALEX A. ADJEI
• 金额: $ 10.8万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-28 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714441
• 关键词: Antigens; Basic Science; CTAG1 gene; Calcitriol; Cancer Center Support Grant; Cholecalciferol; Clinical; Clinical Research; Clinical Trials; Collection; Colon Carcinoma; Data; Development; Diet; Doctor of Philosophy; Dose; Drug Kinetics; Evaluation; Faculty; Foundations; Funding; Future; Gefitinib; Glycemic Index; Grant; HPPH; Head and Neck Cancer; Malignant Neoplasms; Malignant neoplasm of ovary; Numbers; Operative Surgical Procedures; Peer Review; Pharmacodynamics; Phase; Phase I Clinical Trials; Photochemotherapy; Photosensitizing Agents; Pilot Projects; Prognostic Marker; Protocols documentation; Quality Control; Recruitment Activity; Research Personnel; Research Support; Resected; Resource Sharing; Resources; Roswell Park Cancer Institute; Selenium; Selenomethionine; Solid Neoplasm; Testing; Vaccination; Vaccines; Vitamin D; Yang; base; breast density; innovation; irinotecan; member; novel diagnostics; novel therapeutics; preclinical study; programs

Roswell Park Cancer Institute (RPCI) has considerable expertise in the development and conduct of pilot, phase I and phase I/I I studies, which are the foundation for the development of novel therapeutic approaches in hematologic and solid tumor malignancies. The Protocol-Specific Research Support (PSRS) Resource supports the conduct of innovative pilot, phase I and phase l/ll clinical investigations developed by RPCI investigators and emanating from the CCSG Programs. The continued vitality and translational potential of CCSG Programs relies critically on this support for early phase studies. With the recent recruitment of a number of new investigators to the CCSG Programs and RPCI, it is anticipated that accrual will increase substantially over the next several years. Alex A. Adjei, MD, PhD has been recruited to RPCI and now serves as director of this Resource. The primary responsibilities of the clinical research coordinators in this Resource are the implementation, conduct, oversight, collection and quality control of data for phase I and pilot studies. Dr. Adjei oversees the prioritization for the use of PSRS resources in his capacity as Associate Director for Clinical Research and Director of Clinical Shared Resources. In order to be eligible for PSRS, the study must be led by an RPCI investigator or have resulted from clinical or preclinical studies performed by an RPCI investigator with an RPCI faculty member as a co-investigator. Over the last grant period, a number of studies have been activated based on basic research findings of CCSG investigators in vitamin D, selenium and the NY-ESO-1 antigen, among others. Examples include a pilot study of low and high dose vitamin D3 with pharmacokinetic and pharmacodynamic correlates in resected colon cancer (Fakih, Trump and Johnson), calcitriol combined with gefitinib, selenomethionine and irinotecan (Fakih) and NY-ESO-1 antigen vaccination for ovarian cancer (Odunsi). A new photosensitizer for photodynamic therapy, HPPH has been tested in a phase I study (Henderson). Future development continues. A study of surgery combined with intra-operative photodynamic therapy in head and neck cancers is ongoing (Rigual). Other studies include a pilot study of the effect of low glycemic index diet on breast density (McCann), Hsp-based vaccines (Subjeck, Kane, Yang), and novel diagnostic/prognostic marker evaluations - FRA12/SMRT (Coignet, Trump). All these projects were developed with, have led to, or are future components of peer-reviewed funding support.

罗斯威尔公园癌症研究所(RPCI)在开发和实施 试点、I期和I/I期研究，这些研究是开发新疗法的基础 血液病和实体瘤恶性肿瘤的手术入路。特定于协议的研究支持(PSR) 资源支持开展由以下机构开发的创新试点、I期和L/11期临床研究 RPCI调查人员和CCSG计划产生的。持续的活力和翻译性 CCSG项目的潜力在很大程度上依赖于这种对早期研究的支持。随着最近的 为CCSG方案和RPCI招募了一些新的调查员，预计应计 在接下来的几年里将大幅增加。亚历克斯·A·阿德吉，医学博士，博士，已被招募到RPCI 现在担任这一资源的主管。 本资源中临床研究协调员的主要职责是实施， 第一阶段和试点研究数据的执行、监督、收集和质量控制。Adjei博士负责监督 以临床研究和研究副主任的身份确定使用PSRS资源的优先顺序 临床共享资源总监。为了有资格获得PSR，这项研究必须由RPCI领导 研究人员的临床研究或临床前研究的结果，或由具有 作为合作调查员的RPCI系教员。在过去的赠款期间，已经进行了一些研究 根据CCSG研究人员在维生素D、硒和NY-ESO-1方面的基本研究结果而激活 抗原，以及其他。例子包括低剂量和高剂量维生素D3的药代动力学的初步研究 在切除的结肠癌(Fakih，Trump和Johnson)中，联合应用骨化三醇与药效学相关 吉非替尼、硒蛋氨酸和伊立替康联合NY-ESO-1抗原免疫治疗卵巢癌 (奥敦西)。一种用于光动力疗法的新型光敏剂HPPH已在I期研究中进行了测试 (亨德森)。未来的发展还在继续。手术联合术中光动力疗法的研究 头颈部癌症的治疗正在进行中(右图)。其他研究包括对Low的影响的初步研究 关于乳房密度的血糖指数饮食(McCann)、基于HSP的疫苗(Subjeck、Kane、Yang)和新型 诊断/预后标志物评估-FRA12/SMRT(Coignet，Trump)。所有这些项目都是 与同行评审资金支持一起开发的、已经导致的或未来将成为其组成部分的。