drugset / Trial / NCT00629200
Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | interferon alfa-2b | Protein / enzyme biologic | 3e+06 iu | Subcutaneous |
| Subject | sodium stibogluconate | Unknown | 400 mg/m2 | Intravenous |