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Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009502
Recruitment Status : Terminated (Lack of funding, never moved into the phase II portion that was originally planned.)
First Posted : November 6, 2009
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Elizabeth Eklund, Northwestern University

Brief 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.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: sodium stibogluconate Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
Study Start Date : July 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium stibogluconate
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.
Drug: sodium stibogluconate
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.




Primary Outcome Measures :
  1. determine the effect of SSG treatment on clinical parameters of MDS [ 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 ]
    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.

  2. Determine the effect of SSG treatment on hematopoiesis in MDS subjects [ 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009502


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Jesse Brown VHA Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Northwestern University
Robert H. Lurie Cancer Center
Investigators
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Principal Investigator: Elizabeth Eklund, MD Northwestern University
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Responsible Party: Elizabeth Eklund, Elizabeth Eklund, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01009502    
Other Study ID Numbers: NU 08H4
2008-0807 ( Other Identifier: University of Illinois at Chicago IRB )
STU00005048 ( Other Identifier: Northwestern University IRB )
NCI-2010-02059 ( Other Identifier: NCI CTRP# )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics