Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT00629200|
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : November 15, 2018
-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|
|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|
|Actual Study Start Date :||September 13, 2006|
|Actual Primary Completion Date :||February 10, 2010|
|Actual Study Completion Date :||February 10, 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: SSG
Drug: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|