CLINICAL TRIAL: BEXXAR COMBINED WITH EXTERNAL BEAM RADIATION THERAPY FOR PATIENT

临床试验：BEXXAR 结合外照射治疗患者

• 批准号: 7717921
• 负责人: Susan J. Knox
• 金额: $ 0.05万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717921
• 关键词: B-Cell NonHodgkins Lymphoma; Biodistribution; Caring; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disorder by Site; Dose; External Beam Radiation Therapy; Funding; Grant; Hour; Infusion procedures; Institution; Methodology; Monoclonal Antibody CD20; Non-Hodgkin' s Lymphoma; Patients; Phase II Clinical Trials; Platelet Count measurement; Purpose; Radionuclide Imaging; Relapse; Research; Research Personnel; Resources; Safety; Schedule; Source; Standards of Weights and Measures; Therapeutic; Time; United States Food and Drug Administration; United States National Institutes of Health; day; iodine-131-tositumomab; tositumomab

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. This is a single institution Phase II study to determine the efficacy and safety of Bexxar (Tositumomab anti-CD20 monoclonal antibody and 131I-tositumomab) combined with external beam radiation therapy in patients with relapsed, bulky Non-Hodgkin's Lymphoma (NHL). A course of therapy will consist of an initial dosimetric/biodistribution study utilizing 450 mg tositumomab i.v. (to optimize biodistribution) followed by 5 mCi 131I on 35 mg of tositumamb i.v., with gamma camera imaging of patients at 3 time points over 7 days for purposes of calculating a patient specific dose/activity of 131I-tositumomab calculated to deliver a whole body absorbed dose of 75 cGy for patients with platelet counts >= 150,000 and 65 cGy for patients with platelet counts >= 100,000 but < 150,000. The therapeutic dose of 131I-tositumomab will be given on 35 mg of tositumomab and preceded by infusion of 450 mg tositumomab 7 days following administration of the dosimetric dose. This is the standard methodology (dose and schedule) for administration of Bexxar as approved by the FDA for the treatment of patients with low grade and transformed B cell NHL. The external beam radiation to the bulky site of disease is considered standard of care, and is not investigational. This treatment will begin within 24 hours of the therapeutic dose of Bexxar.

这个子项目是许多利用 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。列出的机构为 中心，但不一定是研究者所在的机构。 这是一项单机构II期研究，旨在确定Bexxar（托西莫单抗抗CD 20单克隆抗体和131 I-托西莫单抗）联合外照射放疗治疗复发性巨块型非霍奇金淋巴瘤（NHL）患者的疗效和安全性。 一个疗程将包括初始剂量测定/生物分布研究，使用450 mg托西莫单抗静脉注射（以优化生物分布），随后使用5 mCi 131 I/35 mg托西莫单抗静脉注射，在7天内的3个时间点对患者进行伽马照相机成像，以计算131 I-托西莫单抗的患者特定剂量/活性，计算结果显示，血小板计数≥ 150，000的患者全身吸收剂量为75 cGy，血小板计数≥ 100，000但<150，000的患者全身吸收剂量为65 cGy。 治疗剂量的131 I-托西莫单抗将在35 mg托西莫单抗的基础上给药，并在剂量测定剂量给药后7天输注450 mg托西莫单抗。 这是FDA批准用于治疗低级别和转化B细胞NHL患者的Bexxar给药的标准方法（剂量和时间表）。 对大体积病变部位的外部射束辐射被认为是标准治疗，而不是研究性治疗。 该治疗将在Bexxar治疗剂量后24小时内开始。