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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

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Trial Information

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.


Inclusion Criteria:



- Documented myelodysplastic syndromes (MDS), including therapy-related MDS

- Meets 1 of the following criteria:

- Refractory to prior azacitidine or decitabine

- Did not tolerate treatment with azacitidine or decitabine due to cytopenias or
other side effects

- Not a candidate for azacitidine or decitabine due to cytopenias or other medical
conditions that would contraindicate nucleoside analogues

- Refused treatment with azacitidine or decitabine

- Life expectancy ≥ 16 weeks

- Not pregnant or nursing

- No B12 deficiency, folate deficiency, or pyridoxine responsive anemia as confirmed by
relevant laboratory testing

- No prolongation of QTc or ventricular ectopic beats on EKG

- No evidence of cardiac disease

- No active infection AND afebrile

- More than 21 days since prior azacitidine or decitabine

- More than 21 days since other prior treatment for MDS (e.g., thalidomide, valproic
acid, or other agents as part of a clinical trial)

- Prior cytokines (e.g., erythropoietin, G-CSF, and GM-CSF) allowed

- Prior chemotherapy and/or radiotherapy for solid tumors or lymphoma allowed provided
there is no evidence of active disease from the prior malignancy

Exclusion Criteria:

- Prior treatment for leukemia (e.g., acute myeloid leukemia, chronic myelogenous
leukemia, acute lymphocytic leukemia, or chronic lymphocytic leukemia)

- Concurrent cytokines

- Concurrent antileukemic treatment, including bone marrow transplantation and
radiotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

determine the effect of SSG treatment on clinical parameters of MDS

Outcome Description:

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.

Outcome 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

Safety Issue:

No

Principal Investigator

Elizabeth Eklund, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

NU 08H4

NCT ID:

NCT01009502

Start Date:

July 2009

Completion Date:

July 2015

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Northwestern UniversityChicago, Illinois  60611
Jesse Brown VHA Medical CenterChicago, Illinois  60612