NU 02H8: A PHASE I TRIAL OF REDOX REGULATION IN PATIENTS WITH RELAPSED NHL

NU 02H8：复发 NHL 患者氧化还原调节的 I 期试验

• 批准号: 7604257
• 负责人: Andrew M Evens
• 金额: $ 12.52万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604257
• 关键词: NU; 02H8; PHASE; TRIAL; REDOX

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The potential subject is being asked to participate in this research study because he/she has cancer of the lymph glands (called B-cell lymphoma) that has either not responded to standard treatment or has returned after having shrunk in size or disappeared following previous chemotherapy or radiation treatments. Additional standard chemotherapy could cause the subject's disease to shrink or even disappear completely; however, experience has shown that the cancer will eventually come back. This research study involves the use of two therapies, Rituxan and (90)Yttrium-Zevalin, in combination with an investigational drug, Motexafin Gadolinium (MGd). Both Rituxan and (90)Yttrium-Zevalin are approved by the Food and Drug Administration (FDA) to treat lymphoma. Motexafin Gadolinium (MGd) is not currently approved by the FDA. Rituxan and (90)Yttrium-Zevalin are monoclonal antibodies. A monoclonal antibody is a laboratory-produced substance that reacts with a specific protein antigen (substance foreign to the body). Rituxan combines with a protein found on lymphoma cells and stimulates the body's immune system to destroy the lymphoma cells. (90)Yttrium-Zevalin is radioactive mouse antibodies, which also bind to this protein and carry small particles of radioactivity to help identify (in scans) and kill lymphoma cells to possibly cause the disappearance of the subject's disease. (90)Yttrium-Zevalin is a type of radiation therapy. The study drug, MGd, has been used in combination with radiation therapy in prior clinical studies for subjects receiving radiation to the brain and chest. The drug has been used in combination with radiation to improve the results of radiation. STUDY OBJECTIVE - The purpose of this research study is: 1.) To determine the highest dose of MGd that can be safely combined with (90)Yttrium-Zevalin and Rituxan therapy. 2.) To determine the side effects of this anti-lymphoma therapy; and 3.) To evaluate whether the study treatment can slow, decrease or stop growth of the subject's lymphoma.

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 潜在受试者被要求参加本研究，因为他/她患有淋巴腺癌（称为B细胞淋巴瘤），对标准治疗无反应，或在既往化疗或放疗后体积缩小或消失后复发。 额外的标准化疗可能导致受试者的疾病缩小甚至完全消失;然而，经验表明癌症最终会复发。 这项研究涉及使用两种疗法，Rituxan和（90）Yttrium-Zevalin，与研究药物Motexafin Gadolinium（MGd）联合使用。 Rituxan和（90）Yttrium-Zevalin都被美国食品和药物管理局（FDA）批准用于治疗淋巴瘤。 Motexafin Gadolinium（MGd）目前尚未获得FDA批准。 Rituxan和（90）Yttrium-Zevalin是单克隆抗体。 单克隆抗体是一种实验室生产的物质，可与特定的蛋白质抗原（身体外来物质）反应。 Rituxan与淋巴瘤细胞上的一种蛋白质结合，刺激人体免疫系统摧毁淋巴瘤细胞。 （90）钇-泽娃灵是放射性小鼠抗体，其也与该蛋白质结合并携带放射性小颗粒以帮助识别（在扫描中）和杀死淋巴瘤细胞，从而可能导致受试者的疾病消失。 （90）钇-泽娃灵是一种放射疗法。 在既往临床研究中，研究药物MGd已与放射治疗联合用于接受脑部和胸部放射治疗的受试者。 这种药物已与放射线联合使用，以改善放射线的效果。 研究目的-本研究的目的是：1.）确定可以安全地与（90）钇-Zevalin和Rituxan治疗联合使用的MGd的最高剂量。2.）的情况。确定这种抗淋巴瘤疗法的副作用;和3.）评价研究治疗是否可以减缓、减少或停止受试者淋巴瘤的生长。