INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT MEL-14 F(AB')2 IN LEPTOMENINGEAL TUMORS

该协议包含两个组件，每个组件分配一个单独的Duke IRB 数。第一组分利用131I标记的ME1-14F(ab‘)2 单抗片段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标记的ME1-14F(ab‘)2单抗片段在慢性粒细胞白血病患者中的表达 转移到软脑膜的肿瘤。第二个组件利用 131I标记ME1-14F(ab‘)2单抗片段在治疗中的应用 原发或转移性恶性黑色素瘤和其他脑部疾病的患者 通过手术产生囊性切除空洞的肿瘤。目的 本研究旨在确定阿司匹林的安全性和最大耐受量 131I标记的ME1-14F(ab‘)2单抗片段 进入手术造成的囊性肿瘤切除腔内的患者 原发或转移性恶性黑色素瘤及其他脑肿瘤。两者都有 疾病实体是毁灭性的，不可治愈的神经系统并发症 目前的治疗方法不充分的癌症。的发展。 单抗已经提供了更具特异性的可能性 对单抗或单抗反应的肿瘤的治疗 抗体片段。针对肿瘤细胞的抗体和 与正常大脑或脊髓不起反应的物质可以与 治疗性放射性同位素，如131I。然后，该共轭可以是 用于软脑膜肿瘤的鞘内注射或进入 手术为脑肿瘤创造的切除腔提供了一个 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 two components, each assigned a separate Duke IRB number. The first component utilizes 131Iodine-labeled Me1-14 F(ab')2 monoclonal antibody fragment 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 Me1-14 F(ab')2 monoclonal antibody fragment in patients with neoplasms metastatic to the leptomeninges. The second component utilizes 131I-labeled Me1-14 F(ab')2 monoclonal antibody fragment in the treatment of patients with primary or metastatic malignant melanoma and other 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 Me1-14 F(ab')2 monoclonal antibody fragment administered into surgically created cystic tumor resection cavities in patients with primary or metastatic malignant melanoma and other brain tumors. Both disease entities are 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 or into a surgically-created resection cavity for 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.