A PHASE IB TRIAL OF LEVAMISOLE ALONE AND IN COMBINATION WITH RIFN-GAMMA

该方案的目的是使用以下方法再次观察左旋咪唑： 现代的免疫学检测方法来确定 或左旋咪唑给药时间表， 最大的免疫调节 这项试验还旨在将联合收割机 左旋咪唑与干扰素γ，一种细胞因子， 在之前的两次试验中， 生物反应调节剂计划。 该试验研究了四种不同剂量的左旋咪唑， 一天一次，隔一天一次。 两组患者接受了治疗，一组 辅助治疗组肿瘤负荷小，另一组肿瘤负荷大， 在晚期疾病环境中的肿瘤负荷。 经过两周的 在单独使用左旋咪唑治疗的情况下，所有患者均接受 相同剂量的左旋咪唑加干扰素γ 0.1 mg/m2皮下注射， 那天 本研究确定左旋咪唑在10 mg/kg剂量水平下具有毒性 在两组患者中。 因此，定义了最大耐受剂量 每隔一天5 mg/kg。 在该剂量水平下，治疗效果良好 左旋咪唑单独和左旋咪唑加干扰素γ耐受。 迄今为止进行的免疫学试验分析 表明左旋咪唑在一定剂量下能增强自然杀伤细胞活性- 依赖的方式。 有一种说法是， 辅助设置。 可溶性白细胞介素2受体水平升高 在联合治疗期间。

The purpose of this protocol was to take a second look at Levamisole using modern immunological assays in order to determine if there would be a dose of Levamisole or a schedule of Levamisole administration that would produce maximal immunomodulation. This trial was also designed to combine Levamisole with interferon gamma, a cytokine whose immunostimulating properties has been well defined in two previous trials conducted at the Biological Response Modifiers Program. This trial investigated four different doses of Levamisole administered once a day every other day. Two groups of patients were treated, one with small tumor burdens in the adjuvant setting and another group with large tumor burdens in the advanced disease setting. After two weeks of treatment with Levamisole alone, all patients then were treated with the same dose of Levamisole plus interferon gamma 0.1 mg/m subcutaneously every other day. This study determined that Levamisole was toxic at the 10 mg/kg dose level in both groups of patients. A maximum tolerated dose therefore was defined to be 5 mg/kg every other day. At this dose level, treatment was well tolerated with Levamisole alone and with Levamisole plus interferon gamma. Analysis of the immunological assays that have been performed to date indicate the Levamisole enhances natural killer cell activity in a dose- dependent manner. There was a suggestion that the activity was better in the adjuvant setting. Soluble interleukin-2 receptor levels were increased during the combined therapy.