Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

This phase I/II trial is studying the side effects of sodium stibogluconate and to see how well it works in treating patients with myelodysplastic syndromes.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Elizabeth Eklund, MD

Principal Investigator

Elizabeth Eklund, MD		Ph: 312-503-4625
		Email: e-eklund@northwestern.edu

Study Coordinator		Ph: 312-695-1301
		Email: cancertrials@northwestern.edu

U.S.A.
Illinois
	Chicago
	Jesse Brown VHA Medical Center
		Elizabeth Eklund, MD	Ph: 312-503-4625
			Email: e-eklund@northwestern.edu
		Elizabeth Eklund, MD	Principal Investigator
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Elizabeth Eklund, MD	Ph: 312-503-4625
			Email: e-eklund@northwestern.edu
		Elizabeth Eklund, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01009502
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top