Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

NCT01009502 | Terminated Phase 1 DMC

• 4 other identifiers: NU 08H42008-0807STU00005048NCI-2010-02059
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Study Arms (1)

Sodium stibogluconate

EXPERIMENTAL

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

Interventions

sodium stibogluconate DRUG

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.

Sodium stibogluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Robert H. Lurie Cancer Center: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Jesse Brown VHA Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Antimony Sodium Gluconate

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Elizabeth Eklund, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elizabeth Eklund, MD

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2013
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

US (2)