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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。潜在的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），要么对标准治疗没有反应，要么在先前的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会使患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。这项研究包括使用两种疗法，Rituxan和（90）钇泽伐林，与研究药物Motexafin Gadolinium （MGd）联合使用。Rituxan和（90）钇-泽伐林均已获得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的批准。Rituxan和（90）钇-泽瓦林是单克隆抗体。单克隆抗体是一种实验室生产的物质，它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）钇泽瓦林是一种放射性小鼠抗体，它也与这种蛋白质结合，并携带放射性小颗粒，帮助识别（在扫描中）和杀死淋巴瘤细胞，可能导致受试者的疾病消失。（90）钇泽瓦林是一种放射疗法。在先前的临床研究中，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。该药物已与放疗联合使用，以改善放疗效果。研究目的-本研究的目的是：1.)确定MGd与（90）钇泽伐林和利妥昔单抗联合用药的最高剂量。2)。确定这种抗淋巴瘤疗法的副作用；和3)。评估研究治疗是否能减缓、减少或停止受试者淋巴瘤的生长。

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 shrunken 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.