PHASE I EVALUATION OF SODIUM STIBOGLUICONATE

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。潜在的假设是，葡萄糖酸锑钠在耐受和安全剂量下，通过抑制SHP-1和/或SHP-2，将导致干扰素刺激的基因表达增加。将入组4个连续队列，每个队列6例患者。所有患者将从第1天开始接受SSG IV给药。第1个患者队列将接受SSG 400 mg/m2/天给药，每周5天，第1天至第26天（周一至周五，包括周五）。SSG的该起始剂量<用于治疗内脏利什曼病的剂量的50%。SSG剂量将随连续队列递增，但队列内剂量不会递增。从每个周期的第2天开始，以3 MU/m2的剂量每天SC给予所有患者IFN-α 2b，持续25天。在2周的休息期后，可以使用与上述相同的给药方案开始IFN-α 2 b和SSG的第二个周期。周期将持续至疾病进展或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.