drugset / Trial / NCT00629200

Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies

NCT00629200

NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: -To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies. Secondary Objectives: * To correlate the AUC of SSG with clinical toxicity and efficacy. * To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal transduction pathways. * To characterize the effects of SSG on PTPases SHP-1 and SHP-2. * To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

Timeline

Start
2006-09-13
Primary completion
2010-02-10
Completion
2010-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject interferon alfa-2b Protein / enzyme biologic 3e+06 iu Subcutaneous
Subject sodium stibogluconate Unknown 400 mg/m2 Intravenous