Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies
|ClinicalTrials.gov Identifier: NCT00629200|
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : November 23, 2011
-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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Solid Tumors||Drug: Sodium Stibogluconate Drug: Interferon Alpha-2b||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, 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|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
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
- Maximum tolerated dose (MTD) of SSG in combination with IFN alpha2b [ Time Frame: Continuous assessment with each 3 week cycle ]MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629200
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||M.D. Anderson Cancer Center|