MONOCLONAL ANTIBODY 81C6 131I METASTATIC TO LEPTOMENINGES

该GCRC方案包括两个相关的单抗II期研究 抗体81C6在脑肿瘤患者治疗中的应用81C6是一种 抗胶质瘤抗体已显示与大多数 乳腺癌。第一项研究检测鞘内单抗 81C6治疗肿瘤性脑膜炎或脑膜炎 术后囊腔与脑脊液相通。乳房患者 癌症易受软脑膜转移的影响，目前 对于这种情况，现有的治疗方法是不够的。主要资格 这项研究的标准包括：1)细胞学或放射学证据 蛛网膜下腔的恶性肿瘤，以及2)有反应性的证据 肿瘤细胞中含有81C6。在治疗之前，外周干细胞将 被收集和保存。它们将被用于血液病 毒性。在注射抗体前的48小时内，患者 每天两次，每次2滴，配以水或果汁。这将是 治疗结束后继续治疗28天。有无线电标记的 抗体将以单剂形式通过脑室或 囊内导管。在注射的时候，紧急药物， 包括肾上腺素和苯那君，将可用。注射将是 在住院病房进行管理，所以所有其他急救设施都将 有空。剂量为10毫克的抗体和60毫克的 放射性核素(131I)。18岁的患者将接受一剂治疗 60 mCI中1例患者m2/1.73。剂量将每隔4周重复一次 直到造血毒性需要输注外周干细胞或 直到满足任何其他课外标准。没有明显的毒性 预料之中，虽然骨髓抑制，肝脏损伤，和证据 对中枢神经系统的辐射损伤是理论上的 可能性。已经有三名患者(2WM，1WF)参加了这项研究 议定书自其激活以来。一名患者的X线片表现稳定 经过8个疗程的评估后病情发展 进行性疾病。两名患者在术后出现放射学稳定的疾病 他们的第一次评估，但出现了血液毒性，不能 接受进一步治疗。所有患者均经历3级或更高级别 中性粒细胞减少和/或血小板减少的毒性 输血。我们预计会有更多的收益，而且这项协议仍然开放。

This GCRC protocol comprises two related phase II studies of monoclonal antibody 81C6 in the treatment of patients with brain tumors. 81C6 is an anti-glioma antibody that has demonstrated cross-reactivity with most breast cancers. The first study examines intrathecal monoclonal antibody 81C6 in the treatment of patients with neoplastic meningitis or postoperative cystic cavity communicating with CSF. Patients with breast cancer are susceptible to leptomeningeal metastasis, and currently available treatments for this condition are inadequate. Major eligibility criteria for this study include: 1) cytological or radiographic evidence of malignancy in the subarachnoid space, and 2) evidence of reactivity of the tumor cells with 81C6. Prior to treatment, peripheral stem cells will be collected and saved. They will be used in the event of hematologic toxicity. For 48 hours prior to the antibody administration, patients will take 2 drops of SSKI twice daily with water or juice. This will continue for 28 days after treatment is administered. The radiolabeled antibody will be delivered as a single dose via an intraventricular or intracystic catheter. At the time of injection, emergency drugs, including epinephrine and benadryl, will be available. Injections will be administered on an in-patient unit, so all other emergency facilities will be available. The dose will be 10 mg of antibody and 60 mCi of radionuclide (131I). Patients < 18 years old will be treated with a dose of 60 mCi a patient m2/1.73. Doses will be repeated at 4 week intervals until hematopoietic toxicity requires infusion of peripheral stem cells or until any other off-study criteria is met. No significant toxicity is anticipated, although bone marrow suppression, liver injury, and evidence of radiation damage to the central nervous system are theoretical possibilities. Three patients (2WM, 1WF) have been enrolled on this protocol since its activation. One patient had radiographic stable disease after evaluation at 8 courses of treatment then developed progressive disease. Two patients had radiographic stable disease after their first evaluation, but developed hemotological toxicity and could not be treated further. All patients experienced grade 3 or greater toxicities of neutropenia and/or decreased platelets and received transfusions. We expect further accrual, and this protocol remains open.