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Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311558
Recruitment Status : Terminated
First Posted : April 6, 2006
Last Update Posted : January 26, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells. Giving sodium stibogluconate together with interferon may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon in treating patients with advanced solid tumors, lymphoma, or myeloma.

Condition or disease Intervention/treatment Phase
Cancer Biological: recombinant interferon alfa-2b Drug: sodium stibogluconate Drug: SSG & interferon Phase 1

Detailed Description:



  • Confirm the tolerance, safety, and maximum tolerated dose of sodium stibogluconate (SSG) in combination with interferon alfa-2b in patients with advanced solid tumors, lymphoma, or myeloma.


  • Quantify the effect of SSG on interferon alfa-2b-induced gene modulation and signal transduction pathways by measurement of the serum-soluble gene products β-2 microglobulin, immune serum globulin 15, and neopterin.
  • Define the effectiveness of SSG in inhibiting the protein tyrosine phosphatases src homology proteins (SHP)-1 and SHP-2 assayed from peripheral blood leukocytes of patients receiving SSG in combination with interferon alfa-2b.
  • Define pharmacokinetics of SSG in serum at escalating doses.
  • Assess clinical response to the combination of SSG and interferon alfa-2b.

OUTLINE: This is an open-label, dose-escalation study of sodium stibogluconate (SSG).

Patients receive SSG IV over 15 minutes on days 1, 15-19, and 22-26 and interferon alfa-2b subcutaneously daily on days 8-12 and 15-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of SSG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma
Study Start Date : October 2005
Actual Primary Completion Date : May 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: SSG & INF
1 arm study: SSG & interferon
Biological: recombinant interferon alfa-2b
SSG x 5 week
Other Name: Sodium Stibocluconate

Drug: sodium stibogluconate

Drug: SSG & interferon
1 arm study with SSG & interferon
Other Name: Sodium Stiboglucante

Primary Outcome Measures :
  1. Tolerance, safety, and maximum tolerated dose at 1 week after each course [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignancy, including, but not limited to, any of the following:

    • Renal cell carcinoma
    • Melanoma
    • Kaposi's sarcoma
    • Breast, prostate, colorectal, or lung adenocarcinoma
    • Bone and soft tissue sarcomas
    • Lymphoma
    • Myeloma
    • Tumors of neuroendocrine and endothelial cell origin
  • Stage IV disease
  • Refractory disease, resistant to established treatments, or no effective treatment available
  • Measurable or evaluable disease
  • CNS metastases allowed if no prior definitive therapy within the past 3 months and no glucocorticoids required


  • ECOG performance status 0-1
  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Creatinine < 1.0 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 mL/min
  • Bilirubin < 1.5 times ULN
  • AST/ALT < 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No history of any of the following:

    • Atrial fibrillation, atrial flutter, or other serious arrhythmia (excluding asymptomatic atrial and ventricular premature complexes)
    • Congestive heart failure currently requiring treatment
    • Angina pectoris
    • Other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease)
  • No baseline ECG abnormalities suggestive of cardiac conduction delay, i.e., 1° or greater atrio-ventricular block and/or complete or incomplete (QRS > 120 ms) bundle branch block, or repolarization abnormalities (i.e., QTc ≥ 0.48 sec)
  • No systemic infections requiring antibiotics within the past 14 days
  • No known hepatitis B surface antigen positivity
  • Psychologically prepared to participate in study treatment


  • See Disease Characteristics
  • At least 4 weeks since prior interferon (IFN) therapy and/or ≤ 400 million units of IFN
  • At least 3 weeks since prior major surgery
  • At least 3 weeks since prior radiation therapy or chemotherapy
  • No prior solid organ allografts or allogeneic bone marrow transplantation
  • No concurrent daily glucocorticoids except for physiological replacement
  • No other concurrent medications known to prolong QT interval

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311558

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United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
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Study Chair: Ernest C. Borden, MD The Cleveland Clinic
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Responsible Party: The Cleveland Clinic Identifier: NCT00311558    
Other Study ID Numbers: CASE-CCF-7059
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CCF-7509 ( Other Identifier: IRB number )
CASE-CCF-1062 ( Other Identifier: IRB number )
CASE 2Y06 ( Other Identifier: IRB Number )
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by The Cleveland Clinic:
stage IV melanoma
stage IV adult soft tissue sarcoma
recurrent melanoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferon alpha-2
Antimony Sodium Gluconate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Antiplatyhelmintic Agents