Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

Official title: SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

Status Terminated

Clinical Trial Summary

Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

This was originally designed as a phase I/II trial studying the side effects of sodium stibogluconate and how well it works in treating patients with myelodysplastic syndromes. Unfortunately, due to funding issues, the phase II portion was never conducted.

Clinical Trial Description

Patients receive sodium stibogluconate IV over 30 minutes on days 1-5 and 15-19. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond to treatment may continue therapy until disease progression.

Patients undergo bone marrow aspiration, biopsy, and peripheral blood sample collection periodically for correlative laboratory studies.

After completion of study treatment, patients are followed up at 8 weeks.

The phase II portion of this trial was never conducted due to lack of funding. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT01009502
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: Phase 1
• Start date: July 2009
• Completion date: May 2013