PHASE I EVALUATION OF SODIUM STIBOGLUICONATE

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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.