MONOCLONAL ANTIBODY 81C6-I-131 METASTATIC TO LEPTOMENINGES

该协议包含三个组件，每个组件都分配了一个单独的公爵 IRB编号。第一组分利用131I标记的81C6 单抗在肿瘤患者治疗中的应用 转移到软脑膜。这项研究的目的是 确定鞘内注射的安全性和最大耐受量 ~(131)I标记81C6单抗在肿瘤患者中的应用 转移到软脑膜。第二个组件利用 ~(131)I标记81C6单抗治疗慢性粒细胞白血病 原发或转移性恶性脑肿瘤 囊性切除空洞。这项研究的目的是确定 ~(131)I标记81C6单抗的安全性和最大耐受量 抗体在手术后囊性肿瘤切除术中的应用 原发或转移性恶性脑肿瘤患者的空洞。 第三个组件利用131I标记的81C6单抗在 复发性囊性胶质瘤的治疗。这样做的目的是 研究是为了确定安全和最大耐受量 ~(131)I标记的~(81)C6单抗自然注射入人体 复发性囊性胶质瘤患者出现肿瘤囊腔。 这些疾病实体都是毁灭性的、无法治愈的神经系统 癌症的并发症，目前的治疗方法不够充分。这个 单抗的发展为更多的 对单抗反应的肿瘤的特异性治疗 抗体或抗体片段。针对肿瘤的抗体 与正常大脑或脊髓不起反应的细胞可能是 与治疗性放射性同位素结合，如131I。这个共轭词 然后可以鞘内注射治疗软脑膜肿瘤，进入 囊性脑肿瘤的自然形成的肿瘤囊腔，或进入 手术创造的切除腔用于实体脑瘤的交付 对肿瘤具有相对特异性的治疗剂量 细胞。放射性标记的单抗可能是一种重要的新技术 这些疾病实体的治疗方式。这是第一次 在美国进行的研究，以测试这种间隔疗法 软脑膜肿瘤和脑肿瘤切除腔的手术治疗 放射性标记的单抗。

This protocol contains three components, each assigned a separate Duke IRB number. The first component utilizes 131Iodine-labeled 81C6 monoclonal antibody in the treatment of patients with neoplasms metastatic to the leptomeninges. The purpose of this study is to determine the safety and maximum tolerated dose of intrathecal 131I-labeled 81C6 monoclonal antibody in patients with neoplasms metastatic to the leptomeninges. The second component utilizes 131I-labeled 81C6 monoclonal antibody in the treatment of patients with primary or metastatic malignant brain tumors with surgically created cystic resection cavities. The purpose of this study is to determine the safety and maximum tolerated dose of 131I-labeled 81C6 monoclonal antibody administered into surgically created cystic tumor resection cavities in patients with primary or metastatic malignant brain tumors. The third component utilizes 131I-labeled 81C6 monoclonal antibody in the treatment of patients with recurrent cystic gliomas. The purpose of this study is to determine the safety and maximum tolerated dose of 131I-labeled 81C6 monoclonal antibody administered into naturally occurring tumor cyst cavities in patients with recurrent cystic gliomas. These disease entities are all devastating, incurable neurologic complications of cancer where present treatments are inadequate. The development of monoclonal antibodies has provided the potential for more specific therapy of tumors which are reactive with the monoclonal antibody or antibody fragment. Antibodies that are specific to the tumor cells and that do not react with normal brain or spinal cord can be conjugated with therapeutic radioisotopes, such as 131I. This conjugate can then be delivered intrathecally for leptomentingeal neoplasms, into a naturally-occurring tumor cyst cavity for cystic brain tumors, or into a surgically-created resection cavity for solid brain tumors to deliver a therapeutic dose of radiation with relative specificity for the tumor cells. Radiolabeled monoclonal antibodies may be a significant new therapeutic modality for these disease entities. These are the first studies in the United States to test such compartmental therapy of leptomeningeal neoplasms and brain tumor resection cavities with radiolabeled monoclonal antibodies.