Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

Northwestern University

Status and phase: Terminated; Phase 1

Conditions: Myelodysplastic Syndromes

Treatments: Drug: sodium stibogluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT01009502

2008-0807 (Other Identifier)

STU00005048 (Other Identifier)

NCI-2010-02059 (Other Identifier)

NU 08H4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Sodium stibogluconate

Experimental group

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.

Treatment:

Drug: sodium stibogluconate