Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

NCT ID: NCT01009502

Last Updated: 2013-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sodium stibogluconate

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert H. Lurie Cancer Center

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Eklund

Elizabeth Eklund, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Eklund, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Jesse Brown VHA Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2008-0807

Identifier Type: OTHER

Identifier Source: secondary_id

STU00005048

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2010-02059

Identifier Type: OTHER

Identifier Source: secondary_id

NU 08H4

Identifier Type: -

Identifier Source: org_study_id