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Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

Primary Purpose

Myelodysplastic Syndromes

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sodium stibogluconate
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • Jesse Brown VHA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium stibogluconate

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2009
Last Updated
November 6, 2013
Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01009502
Brief Title
Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
Official Title
SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding, never moved into the phase II portion that was originally planned.
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium stibogluconate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sodium stibogluconate
Intervention Description
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 Measure Information:
Title
determine the effect of SSG treatment on clinical parameters of MDS
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.
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
Title
Determine the effect of SSG treatment on hematopoiesis in MDS subjects
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Eklund, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Jesse Brown VHA Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

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