SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determine the effect of SSG treatment on clinical parameters of MDS
To determine the effect of SSG treatment on clinical parameters of MDS. This will include determination of cytopenias, bone marrow dysplasia, % myeloid blasts, transfusion frequency, incidence of infection and phagocyte function in MDS subjects pre and during treatment. Serum Sb levels will also be determined as an early indication of toxicity.
Weeks 2 and 4 of each cycle for 24 Weeks then every other month for 6 months then every 3 months for 12 months then every 6 months for 2 years
Elizabeth Eklund, MD
United States: Food and Drug Administration
|Northwestern University||Chicago, Illinois 60611|
|Jesse Brown VHA Medical Center||Chicago, Illinois 60612|