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

本方案包含两个组成部分，每个组成部分均分配有单独的杜克IRB number. 第一种组分利用131碘标记的Me 1 -14 F（ab '）2 用于治疗肿瘤患者的单克隆抗体片段 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Me_（1 -14）F（ab '）_2单克隆抗体片段在乳腺癌患者中的应用 转移到软脑膜的肿瘤。 第二部分利用 131 I标记的Me 1 -14 F（ab '）2单克隆抗体片段在治疗中的应用 原发性或转移性恶性黑色素瘤和其他脑 肿瘤与手术创建的囊性切除腔。的目的 本研究旨在确定安全性和最大耐受剂量 给予131 I标记的Me 1 -14 F（ab '）2单克隆抗体片段 手术创建的囊性肿瘤切除腔， 原发性或转移性恶性黑色素瘤和其他脑肿瘤。 两 疾病实体是毁灭性的，无法治愈的神经系统并发症， 目前治疗方法不充分的癌症。 的发展 单克隆抗体提供了更特异的 治疗与单克隆抗体反应的肿瘤，或 抗体片段。 特异性针对肿瘤细胞的抗体， 不与正常脑或脊髓反应的蛋白质可以与 放射性同位素，如131 I。 然后，该共轭可以是 用于软脑膜肿瘤的鞘内给药或 脑肿瘤切除术的切除腔， 对肿瘤具有相对特异性的放射治疗剂量 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。

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.