IN VITRO DRUG TESTING FOR LIMITED SCLC AND PHASE I DRUG DEVELOPMENT

A.一天两次放疗和VP的联合方案 16/Plat已用于治疗局限性肺癌。 该方案还使用了患者自身的体外药物测试。 肿瘤在12周后选择化疗药物。 患者已进入研究，所有(4/4) 已经完成了治疗，取得了完全的反应 这4个人在11个月、11个月、10个月和6个月后都没有癌症。 从开始治疗开始。目前还没有病人因此而住院 中性粒细胞减少性发热或肺部毒性。 B.使用二氢兰培酮的I期试验，一种被确认为 人体肿瘤对人肺癌的积极抗癌作用 克隆形成试验(HTCFA)已经启动。十五 患者已经在5个剂量水平上进行了研究。主体方面 所有患者的效果都是嗜睡和低血压。 只有一名患者因嗜睡而不得不停止治疗 没有一例是因为低血压。初步药代动力学 测定表明，吸收峰值在3小时，该水平 在12小时的给药间隔内变化小于50%。 从这项研究中我们得出结论，HTCFA已经确定了一个 具有新的副作用和最大耐受性的复方 剂量尚未达到。

A. A protocol combining twice a day radiotherapy and VP- 16/Plat for limited stage lung cancer has been implimented. This protocol also uses in vitro drug testing of the patients own tumor to select chemotherapy agents after week 12. Seven patients have been entered on study and all patients (4/4) who have completed therapy have achieved a complete response and these 4 all continue to be cancer free at 11, 11, 10, and 6 months from starting therapy. No patients have been hospitalized for neutropenic fever or pulmonary toxicity. B. A phase I trial using dihydrolenperone, an agent identified as being active against human lung cancer by the human tumor colony forming assay (HTCFA) has been initiated. Fifteen patients have been studied at 5 dosage levels. The principal side effects have been somnolence and hypotension in all patients. Only one patient has has to stop therapy because of somnolence and none because of hypotension. Preliminary pharmacokinetic determinations show peak absorption at 3 hour and that level vary less than 50% over the 12 hours dosing interval. From this studies we conclude that the HTCFA has identified a compound with novel side effects and the maximum tolerated dose has not been reached.