MONOCLONAL ANTIBODY 81C6 131I METASTATIC TO LEPTOMENINGES

单克隆抗体 81C6 131I 转移至软脑膜

• 批准号: 6273996
• 负责人: MARK T BROWN
• 金额: $ 2.88万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6273996
• 关键词: brain neoplasms; clinical research; human subject; human therapy evaluation; iodine; meningioma; metastasis; monoclonal antibody; neoplasm /cancer immunotherapy; neoplasm /cancer radionuclide therapy

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.

该GCRC方案包括两项相关的单克隆抗体II期研究。 抗体81 C6治疗脑肿瘤患者。 81 C6是一种 抗神经胶质瘤抗体，已证明交叉反应性与大多数 乳腺癌 第一项研究检查了鞘内单克隆抗体 81 C6治疗肿瘤性脑膜炎或 术后囊腔与脑脊液相通。 乳腺 癌症容易发生软脑膜转移，目前 对这种情况的现有治疗是不充分的。 主要资格 本研究的标准包括：1）细胞学或放射学证据 蛛网膜下腔恶性肿瘤的证据，和2） 用81 C6处理肿瘤细胞。 在治疗之前，外周干细胞将 收集并保存。 它们将用于血液学事件 毒性 在抗体施用前48小时，患者 将采取2滴SSKI每日两次与水或果汁。 这将 治疗后持续28天。 放射性标记 抗体将作为单剂量通过脑室内或 囊内导管 在注射时，紧急药物， 包括肾上腺素和苯那君 注射部位 在一个住院单位管理，所以所有其他紧急设施将 随时待命 剂量将是10 mg抗体和60 mCi的抗体。 放射性核素（131 I）。 < 18岁的患者将接受一剂 60 mCi/患者m2/1.73。 将以4周间隔重复给药 直到造血毒性需要输注外周干细胞或 直至满足任何其他研究外标准。 无明显毒性 预期，虽然骨髓抑制，肝损伤，和证据， 对中枢神经系统的辐射损伤是理论上的 可能性 3例患者（2 WM，1 WF）已入组本研究 自启动以来， 1例患者影像学稳定 在8个疗程后评估疾病，然后发展 进行性疾病 两名患者在治疗后放射学稳定 他们的第一次评估，但发展血液学毒性，不能 进一步治疗。 所有患者均发生3级或以上 中性粒细胞减少和/或血小板减少的毒性，并接受 输血 我们预计会有更多的收益，这项协议仍然有效。