BIZELESIN 在晚期癌症患者中的 I 期试验-猫眼课题宝

BIZELESIN 在晚期癌症患者中的 I 期试验

批准号：

6117418

负责人：

H PITOT

金额：

$2.01万

依托单位：

MAYO CLINIC ROCHESTER

依托单位国家：

美国

项目类别：

财政年份：

1998

资助国家：

美国

项目状态：

已结题

起止时间：

1998-12-01 至 1999-11-30

来源：

https://reporter.nih.gov/project-details/6117418

关键词：

alkylating agents antineoplastic antibiotics clinical research clinical trial phase I dosage drug adverse effect drug screening /evaluation human subject neoplasm /cancer chemotherapy pharmacokinetics

中文摘要

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英文摘要

This trial is being conducted to assess the maximum tolerated dose (MTD) of bizelesin in patients with advanced cancer treated once every four weeks. The current trial has nearly complete the accrual goals. A total of 19 patients have been enrolled at five different dose levels. To date, dose limiting toxicities have been encountered at the two highest levels -- 0.8 ug/m2 and 1.0 ug/m2. Several episodes of grade 4 leukopenia and neutropenia have been observed at these dose levels. We continue to follow three patients for ongoing treatment evaluations. Pharmacokinetic sampling is being performed during cycle one. We plan to describe the toxicities of bizelesin given on this schedule and to characterize the pharmacokinetics. Pharmacodynamic relationships will also be explored when the MTD has been determined. The study drug is supplied by the NCI and plans for further investigations are currently pending. The preliminary findings for this trial have been presented at the NCI/EORTC meeting in Amsterdam, June 1998. Updated results were submitted for abstract presentation to American Association for Cancer Research in April 1999.

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