Solid Tumors Clinical Trial
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
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.
Primary objectives:
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 objective:
- 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.
Treatment:
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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