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

该方案的目的是检查免疫学效果， 左旋咪唑使用现代分析技术，以确定是否 左旋咪唑给药的替代剂量和时间表将产生 最大的免疫调节 还给予左旋咪唑， 干扰素-γ是一种细胞因子， 在之前的两次试验中， 生物反应调节剂计划 每隔一天口服左旋咪唑， 不同的剂量水平。 两组患者符合入组条件 在这次审判中。 一组患有晚期转移性疾病， 组（辅助组）在手术治疗后进行治疗， 患者无病。 每隔一天单独给予左旋咪唑 总共六剂，休息十天后， 左旋咪唑与干扰素-γ联合给药，剂量为 0.1每隔一天皮下注射mg/m2，与 左旋咪唑 在10 mg/kg剂量的左旋咪唑下观察到剂量限制性毒性 在两组患者中。 最大耐受剂量定义为5 mg/kg隔日一次。 在该剂量水平下，治疗耐受性良好 单独使用左旋咪唑和左旋咪唑加干扰素γ。

The purpose of this protocol was to examine the immunologic effects of levamisole using modern assay techniques in order to determine if an alternate dose and schedule of levamisole administration would produce maximal immunomodulation. Levamisole was also administered in combination with interferon-gamma, a cytokine whose immunomodulatory properties have been well defined in two previous trials conducted at the Biological Response Modifiers Program. Levamisole was administered orally every other day at one of four different dose levels. Two groups of patients were eligible for entry on this trial. One group had advanced metastatic disease and the second group (adjuvant group) was treated after surgical therapy to render the patient disease free. Levamisole alone was administered every other day for a total of six doses, after a ten-day rest the same dose of levamisole was given in combination with interferon-gamma at a dose of 0.1 mg/m sq subcutaneously every other day on the same days as the levamisole. Dose-limiting toxicity was observed at the 10 mg/kg dose of levamisole in both groups of patients. The maximum-tolerated dose was defined as 5 mg/kg every other day. At this dose level, treatment was well tolerated with levamisole alone and with levamisole plus interferon gamma.