PHASE I EVALUATION OF SODIUM STIBOGLUICONATE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。潜在的假设是，在耐受和安全的剂量下，通过抑制SHP-1和/或SHP-2，将导致干扰素刺激基因表达的增加。4个连续的队列，每个队列6名患者将被纳入。所有患者将从第一天开始接受SSG IV。第一组患者将接受SSG 400mg /m2/天的剂量，为期5天/周，第1天至第26天（周一至周五）。SSG的起始剂量小于治疗内脏利什曼病所用剂量的50%。SSG剂量将随着连续队列的增加而增加，但在队列内剂量不会增加。IFN-a2b将从每个周期的第2天开始，以每天3 MU/m2 SC的剂量给予所有患者，持续25天。休息2周后，第二个周期的IFN-a2b和SSG可以开始使用与上述相同的给药方案。周期将继续，直到疾病进展或DLT发生。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The underlying hypothesis is that sodium stibogluconate at tolerable and safe doses, by inhibition of SHP-1 and/or SHP-2, will lead to an increase in interferon stimulated gene expression. Four successive cohorts of 6 patients each will be enrolled. All patients will receive SSG IV beginning on day The first patient cohort will receive a dose of SSG 400 mg/m2/day for five days/week day 1 through day 26 (Monday through to and including Friday). This starting dose of SSG is <50% of the dose used in the treatment of visceral leishmaniasis. SSG dose will be escalated with successive cohorts, but the dose will not be escalated within cohorts. IFN-a2b will be given to all patients at a dose of 3 MU/m2 SC daily for 25 days beginning on day 2 of each cycle. After a rest period of 2 weeks, a second cycle of IFN-a2b and SSG may begin using the same dosing schema as above. Cycles will continue until disease progression or DLT occurs.