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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Sodium stibogluconate 900 mg/m2/day will be given on Monday through Friday every other week for the first 16 weeks of the study (on the 1st, 3rd, 5th, 7th, 9th, 11th, 13th and 15th weeks). On the alternate weeks patients will not receive any study treatment.
Northwestern University
Chicago, Illinois, United States
Jesse Brown VHA Medical Center
Chicago, Illinois, United States
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.
Time frame: 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
Determine the effect of SSG treatment on hematopoiesis in MDS subjects
To determine the effect of SSG treatment on hematopoiesis in MDS subjects. This will include determination of cytokine hypersensitivity, apoptosis resistance, and altered expression of key HoxA10 and ICSBP target genes in the bone marrow of subjects pre and during treatment.
Time frame: 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
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