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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 潜在受试者被要求参加这项研究，因为他/她患有淋巴腺癌（称为 B 细胞淋巴瘤），该癌症要么对标准治疗没有反应，要么在先前化疗后体积缩小或消失后复发或放射治疗。 额外的标准化疗可能会使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，以及一种研究药物 Motexafin Gadolinium (MGd)。 Rituxan 和 (90)Yttrium-Zevalin 均已获得美国食品和药物管理局 (FDA) 批准用于治疗淋巴瘤。 莫替沙芬钆 (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）发生反应。 Rituxan 与淋巴瘤细胞上发现的蛋白质结合，刺激人体的免疫系统破坏淋巴瘤细胞。 (90)Yttrium-Zevalin 是放射性小鼠抗体，它也与这种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疾病消失。 (90)钇-Zevalin 是一种放射治疗。 在之前的临床研究中，该研究药物 MGd 已与放射治疗联合用于接受大脑和胸部放射治疗的受试者。 该药物已与放射治疗联合使用，以改善放射治疗的效果。 研究目的 - 本研究的目的是： 1.) 确定可安全地与 (90)Yttrium-Zevalin 和 Rituxan 疗法联合使用的 MGd 最高剂量。 2.) 确定这种抗淋巴瘤疗法的副作用； 3.) 评估研究治疗是否可以减缓、减少或停止受试者淋巴瘤的生长。