MONOCLONAL ANTIBODY 81C6-I-131 METASTATIC TO LEPTOMENINGES

单克隆抗体 81C6-I-131 转移至软脑膜

• 批准号: 5215571
• 负责人: MARK T BROWN
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5215571
• 关键词: brain neoplasms; clinical research; clinical trial phase I; drug administration routes; glioma; human subject; human therapy evaluation; immunoconjugates; iodine; meningioma; metastasis; monoclonal antibody; neoplasm /cancer immunotherapy; neoplasm /cancer radionuclide therapy; radiation therapy dosage; radionuclides; radiotracer

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.

该方案包含三个组件，每个组件分配一个单独的杜克 IRB编号。 第一种组分利用131碘标记的81 C6 单克隆抗体在肿瘤治疗中的应用 转移到了软脑膜本研究的目的是 确定鞘内注射的安全性和最大耐受剂量 131 I标记的81 C6单克隆抗体在肿瘤患者中的应用 转移到了软脑膜 第二部分利用 ~（131）I标记的~（81）C_6单克隆抗体治疗原发性肝癌的临床研究 原发性或转移性恶性脑肿瘤， 囊腔切除术 本研究的目的是确定 ~（131）I标记~（81）C_6单克隆抗体的安全性和最大耐受剂量 将抗体施用到手术产生的囊性肿瘤切除术中 原发性或转移性恶性脑肿瘤患者的空洞。 第三种成分利用131 I标记的81 C6单克隆抗体， 复发性囊性胶质瘤患者的治疗。 这样做的目的 研究旨在确定安全性和最大耐受剂量 131 I标记的81 C6单克隆抗体施用到自然 复发性囊性胶质瘤患者中出现肿瘤囊腔。 这些疾病实体都是毁灭性的，无法治愈的神经系统 目前治疗方法不充分的癌症并发症。 的 单克隆抗体的发展提供了更多的潜力， 特异性治疗与单克隆抗体反应的肿瘤 抗体或抗体片段。 肿瘤特异性抗体 不与正常大脑或脊髓反应的细胞， 与治疗性放射性同位素如131 I缀合。 该缀合物 然后可以通过鞘内给药治疗软脑膜肿瘤， 一个自然发生的肿瘤囊肿腔囊性脑肿瘤，或进入 一个为实体脑肿瘤制造的切除空腔， 对肿瘤具有相对特异性的治疗剂量的放射线 细胞放射性标记的单克隆抗体可能是一个重要的新的 这些疾病实体的治疗模式。 这些是第一 在美国进行的测试这种房室疗法的研究， 软脑膜肿瘤和脑肿瘤切除空洞， 放射性标记的单克隆抗体。