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90YCC49 MONOCLONAL ANTIBODY IN ADVANCED NONSMALL CELL LUNG CANCER

90YCC49 MONOCLONAL ANTIBODY IN ADVANCED NONSMALL CELL LUNG CANCER
90YCC49 单克隆抗体治疗晚期非小细胞肺癌
批准号：
6303037
负责人：
FRANCISCO ROBERT
金额：
$2.95万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
项目状态：
已结题
起止时间：
1999-12-01 至 2000-11-30
来源：
https://reporter.nih.gov/project-details/6303037
关键词：
clinical research clinical trial phase I combination cancer therapy combination chemotherapy dosage drug adverse effect drug screening /evaluation ethylenediaminetetraacetate human subject human therapy evaluation immunotherapy interferon alpha monoclonal antibody neoplasm /cancer chemotherapy nonsmall cell lung cancer pharmacokinetics

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中文摘要
翻译
这是一项90Y标记的抗TAG 72鼠(CC49)单抗在晚期非小细胞肺癌患者中的I期研究。本研究的主要目的是确定90Y-CC49的MTD和剂量限制毒性。第二个目标是确定某些药物(EDTA或DPTA)是否可以减轻骨髓抑制，并排除紫杉醇与90Y-CC49的同时输注。剂量限制性毒性为骨髓抑制(4级血小板减少和中性粒细胞减少)。剂量为17 mg/m2时，MTD超标。IN-CC49成像良好，TY2约为47±3小时(单室模型)。
英文摘要
This is a Phase I study of 90Y-labeled anti-tag 72 murine (CC49) monoclonal antibody in patients with advanced non-small cell lung cancer. The primary objective of the study was to determine the MTD and dose-limiting toxicities of 90Y-CC49. Secondary objective was to determine if certain chilators (EDTA or DPTA) could decrease myelosuppression, and to exclude the concomitant infusion of Taxol with 90Y-CC49. Dose limiting toxicity was myelosuppression (grade 4 thromboctopenia and neutropenia). The MTD was exceeded with dose of 17mg/m2. There was adequate imaging with IN-CC49, and the TY2 was approximately 47 + 3 hours (one compartment model.
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