PHASE I TRIAL OF AMINOPTERIN IN PATIENTS WITH REFRACTORY MALIGNANCIES

本研究的目的是（1）建立定性和 儿童和成人氨基蝶呤的定量毒性，（2） 确定急性剂量限制性毒性和恢复时间， (3)以确定是否有累积毒性，（4）建立一个 导致可耐受毒性的氨基蝶呤最大耐受剂量 其是可预测的和可逆的，并且可以用于II期试验， (5)以确定所需的最小甲酰四氢叶酸救援量， 以防止过量的毒性，和（6）确定预防措施， 应该使用的支持疗法。

The purpose of this study is (1) to establish the qualitative and quantitative toxicity of aminopterin in children and adults, (2) to determine the acute dose-limiting toxicities and time(s) to recovery, (3) to determine if there is cumulative toxicity, (4) to establish a maximum-tolerated dose of aminopterin that results in tolerable toxicity which is predictable and reversible and can be used in phase II trials, (5) to determine the minimal amount of leucovorin rescue that is needed to protect from excessive tosicity, and (6) to determine precautions and supportive therapy that should be used.