Mekhail Tarek, Kaur Hanspreet, Ganapathi Ram, Budd G Thomas, Elson Paul, Bukowski Ronald M
Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, 9500 Euclid Ave., Cleveland, OH 44195, USA.
Invest New Drugs. 2006 Sep;24(5):423-7. doi: 10.1007/s10637-006-7772-x.
Anvirzel is an aqueous extract of the plant Nerium oleander which has been utilized to treat patients with advanced malignancies. The current study reports a phase 1 trial to determine the maximum tolerated dose (MTD) and safety of Anvirzel in patients with advanced, refractory solid tumors. Patients were randomized to receive this agent by intramuscular injection at doses of 0.1, 0.2, 0.4 ml/m2/day with subsequent patients receiving 0.8 or 1.2 ml/m2/day sequentially. Eighteen patients were enrolled and completed at least one treatment cycle of three weeks. Most patients developed mild injection site pain (78%). Other toxicities included fatigue, nausea, and dyspnea. Traditional dose limiting toxicity was not seen, but the MTD was defined by injection volume as 0.8 ml/m2/day. No objective anti-tumor responses were seen. Anvirzel can be safely administered at doses up to 1.2 ml/m2/day, with the amount administered intramuscularly limited by volume. The recommended phase II dose level is 0.8 ml/m2/day.
安维泽尔是夹竹桃植物的水提取物，已被用于治疗晚期恶性肿瘤患者。当前研究报告了一项1期试验，以确定安维泽尔在晚期难治性实体瘤患者中的最大耐受剂量（MTD）和安全性。患者被随机分组，通过肌肉注射接受该药物，剂量为0.1、0.2、0.4毫升/平方米/天，随后的患者依次接受0.8或1.2毫升/平方米/天的剂量。18名患者入组并完成了至少一个为期三周的治疗周期。大多数患者出现轻度注射部位疼痛（78%）。其他毒性包括疲劳、恶心和呼吸困难。未观察到传统的剂量限制性毒性，但MTD根据注射体积定义为0.8毫升/平方米/天。未观察到客观的抗肿瘤反应。安维泽尔可以安全地以高达1.2毫升/平方米/天的剂量给药，肌肉注射给药量受体积限制。推荐的II期剂量水平为0.8毫升/平方米/天。
