- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01009502
Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60612
- Jesse Brown VHA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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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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
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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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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Eklund, MD, Northwestern University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU 08H4
- 2008-0807 (OTHER: University of Illinois at Chicago IRB)
- STU00005048 (OTHER: Northwestern University IRB)
- NCI-2010-02059 (OTHER: NCI CTRP#)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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