Study to Evaluate Sodium Stibogluconate With Interferon Alpha-2b
The goal of this clinical research study is to expand the research following finding the highest tolerable dose of sodium stibogluconate combined with interferon alfa-2b in the treatment of patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for this type of cancer.
Drug: Sodium Stibogluconate
Drug: Interferon Alpha-2b
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IIa, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies|
- Maximum tolerated dose (MTD) of SSG in combination with IFN alpha2b [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs. Continuous assessment with each 3 week cycle.
|Study Start Date:||September 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: SSG + Intron A
Sodium Stibogluconate (SSG) 400 mg/m^2 intravenous (IV) daily on days 1-5 + Interferon Alfa-2b (Intron A) 3x10^6 units subcutaneously three times weekly
Drug: Sodium Stibogluconate
400 mg/m^2 IV daily on days 1-5.
Other Name: SSGDrug: Interferon Alpha-2b
3x10^6 units subcutaneously three times weekly
Other Name: Intron A
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.
- 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.
During Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5. On Days 8-12, you will be given sodium stibogluconate once a day by vein, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 8, 10, and 12. For every cycle after Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5 and 8-12, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 1, 3,5, 8, 10, and 12. Treatment cycles will last about 3 weeks (2 weeks on treatment, followed by 1 week off treatment). After Cycle 1, you will be scheduled to return to the clinic in 10 days to receive treatment for Cycle 2, which will follow in the same manner as Cycle 1.