Maria E.L. van der Burg , AndréS.Th. Planting , Gerrit Stoter , Cathy McDaniel , Charles J. Vecht , Jaap Verweij
{"title":"一期研究:每3周给予一次DABIS马来酸盐","authors":"Maria E.L. van der Burg , AndréS.Th. Planting , Gerrit Stoter , Cathy McDaniel , Charles J. Vecht , Jaap Verweij","doi":"10.1016/0277-5379(91)90433-E","DOIUrl":null,"url":null,"abstract":"<div><p>DABIS maleate is an alkylating quaternary nitrogen. In a phase I study DABIS maleate was administered as a single intravenous infusion once every 3 weeks. 32 patients with solid tumours were studied, at least 3 per dose level (50–1400 mg/m<sup>2</sup>). Dose-limiting toxicity was severe paresthaesias in the face, around the mouth and in the tongue. Cerebellar ataxia developed at 750 mg/m<sup>2</sup> or higher. Haematological toxicity was minimal. Nausea and vomiting were mild to moderate. No other non-haematological side-effects were noted. The recommended dose for phase II studies at once every 3 weeks is 750 mg/m<sup>2</sup> intravenously as a 15 min infusion.</p></div>","PeriodicalId":11925,"journal":{"name":"European Journal of Cancer and Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0277-5379(91)90433-E","citationCount":"2","resultStr":"{\"title\":\"Phase I study of DABIS maleate given once every 3 weeks\",\"authors\":\"Maria E.L. van der Burg , AndréS.Th. Planting , Gerrit Stoter , Cathy McDaniel , Charles J. Vecht , Jaap Verweij\",\"doi\":\"10.1016/0277-5379(91)90433-E\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>DABIS maleate is an alkylating quaternary nitrogen. In a phase I study DABIS maleate was administered as a single intravenous infusion once every 3 weeks. 32 patients with solid tumours were studied, at least 3 per dose level (50–1400 mg/m<sup>2</sup>). Dose-limiting toxicity was severe paresthaesias in the face, around the mouth and in the tongue. Cerebellar ataxia developed at 750 mg/m<sup>2</sup> or higher. Haematological toxicity was minimal. Nausea and vomiting were mild to moderate. No other non-haematological side-effects were noted. The recommended dose for phase II studies at once every 3 weeks is 750 mg/m<sup>2</sup> intravenously as a 15 min infusion.</p></div>\",\"PeriodicalId\":11925,\"journal\":{\"name\":\"European Journal of Cancer and Clinical Oncology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1991-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/0277-5379(91)90433-E\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Cancer and Clinical Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/027753799190433E\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Cancer and Clinical Oncology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/027753799190433E","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Phase I study of DABIS maleate given once every 3 weeks
DABIS maleate is an alkylating quaternary nitrogen. In a phase I study DABIS maleate was administered as a single intravenous infusion once every 3 weeks. 32 patients with solid tumours were studied, at least 3 per dose level (50–1400 mg/m2). Dose-limiting toxicity was severe paresthaesias in the face, around the mouth and in the tongue. Cerebellar ataxia developed at 750 mg/m2 or higher. Haematological toxicity was minimal. Nausea and vomiting were mild to moderate. No other non-haematological side-effects were noted. The recommended dose for phase II studies at once every 3 weeks is 750 mg/m2 intravenously as a 15 min infusion.
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