UAB 9846 PHASE I TRIAL OF 131I-HUCC49DCH2 FOR COLON CANCER

UAB 9846 131I-HUCC49DCH2 治疗结肠癌的 I 期试验

• 批准号: 7380408
• 负责人: RUBY F. MEREDITH
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380408
• 关键词: UAB; 9846; PHASE; TRIAL; 131I

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 objectives of this study in patients with metastatic or unresectable colon or rectal cancer, are to: (1) determine the maximum tolerated dose (MTD) of intravenous (IV) 131I-HuCC49ΔCH2 (recombinant humanized murine CC49 antibody with a deleted CH2 region); (2) determine the toxicities, the plasma pharmacokinetics, whole body biodistribution and conjugate stability of IV 131I-HuCC49ΔCH2; (3) determine the ability of 131I-HuCC49ΔCH2 to localize to tumor sites (dosimetry estimates to tumor, normal organs and whole body will be determined); and (4) characterize the human immune response against 131I-HuCC49ΔCH2 and determine the feasibility of administering two treatment infusions. Perspective participants will have preliminary tests conducted to determine their eligibility for enrollement in the study. The first group of patients will receive 10 mCi 131I-HuCC49ΔCH2 as a diagnostic/dosimetry study. Once dosimetry information from this group is obtained, the therapeutic starting dose level will be established for subsequent groups. On the day of antibody infusion, the patient will be closely observed for allegic reaction. To determine whether the antibody has bound to cancer cells, several specialized scans will be conduted during the first week after treatment; blood samples will be collected to determine the effects on blood cells and organ function as well the antibody to determine the antibody levels in the system. Patients will be followed at 6-month intervals for up to two years.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。在患有转移性或不可切除的结肠癌或直肠癌的患者中进行的这项研究的目的是：（1）确定静脉内（IV）131 I-HuCC 49Δ CH 2（具有缺失的CH 2区的重组人源化鼠CC 49抗体）的最大耐受剂量（MTD）;（2）确定IV 131 I-HuCC 49 CH 2的毒性、血浆药代动力学、全身生物分布和缀合物稳定性Δ;（3）确定131 I-HuCC 49 CH 2在结肠癌或直肠癌患者中的耐受性的能力Δ。定位于肿瘤部位（将确定对肿瘤、正常器官和全身的剂量测定估计）;和（4）表征针对131 I-HuCC 49 CH 2的人免疫应答Δ并确定施用两次治疗输注的可行性。未来的参与者将进行初步测试，以确定他们是否有资格参加这项研究。第一组患者将接受10 mCi 131 I-HuCC 49 CH 2作为诊断/剂量测定研究。一旦获得该组的剂量测定信息，将确定后续组的治疗起始剂量水平。在抗体输注当天，将密切观察患者的过敏反应。为了确定抗体是否与癌细胞结合，将在治疗后的第一周进行几次专门的扫描;将收集血液样本以确定对血细胞和器官功能的影响以及抗体以确定系统中的抗体水平。患者将每6个月随访一次，最长随访2年。