Whitehead V M, Bernstein M L, Vega R, Vats T, Dyment P, Vietti T J, Krischer J
McGill University, Montreal, Canada.
Cancer Chemother Pharmacol. 1990;26(5):377-9. doi: 10.1007/BF02897298.
A phase I trial of indicine-N-oxide was carried out in 12 children with solid tumors and in 16 with leukemia. Doses of 5, 6, and 7.5 g/m2 were given parenterally as a 15-min infusion every 3 weeks. The maximum tolerated dose in patients with solid tumors was 7.5 g/m2 and the dose-limiting toxicity was myelosuppression. In leukemia, the maximum tolerated dose was 6.0 g/m2 and hepatotoxicity was dose-limiting. Half of the children with leukemia showed elevations in transaminase levels and one child died of massive hepatic necrosis. This hepatotoxicity limits the use of indicine-N-oxide in children with leukemia. Antineoplastic activity was limited to a transient reduction in the numbers of circulating leukemic cells.
对12名实体瘤患儿和16名白血病患儿进行了氧化氮异喹啉的I期试验。每3周静脉注射15分钟，剂量分别为5、6和7.5 g/m²。实体瘤患者的最大耐受剂量为7.5 g/m²，剂量限制性毒性为骨髓抑制。在白血病患者中，最大耐受剂量为6.0 g/m²，肝毒性为剂量限制性。一半的白血病患儿转氨酶水平升高，一名患儿死于大面积肝坏死。这种肝毒性限制了氧化氮异喹啉在白血病患儿中的应用。抗肿瘤活性仅限于循环白血病细胞数量的短暂减少。
