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Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies

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: NCT00629200
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : November 15, 2018
VioQuest Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Primary Objective:

-To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.

Secondary Objectives:

  • To correlate the AUC of SSG with clinical toxicity and efficacy.
  • To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal transduction pathways.
  • To characterize the effects of SSG on PTPases SHP-1 and SHP-2.
  • To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

Condition or disease Intervention/treatment Phase
Advanced Cancer Solid Tumors Drug: Sodium Stibogluconate Drug: Interferon Alpha-2b Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies
Actual Study Start Date : September 13, 2006
Actual Primary Completion Date : February 10, 2010
Actual Study Completion Date : February 10, 2010

Arm Intervention/treatment
Experimental: SSG + Intron A
Sodium Stibogluconate (SSG) 400 mg/m^2 intravenous (IV) daily on days 1-5 + Interferon Alfa-2b (Intron A) 3x10^6 units subcutaneously three times weekly
Drug: Sodium Stibogluconate
400 mg/m^2 IV daily on days 1-5.
Other Name: SSG

Drug: Interferon Alpha-2b
3x10^6 units subcutaneously three times weekly
Other Name: Intron A

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of SSG in combination with IFN alpha2b [ Time Frame: Continuous assessment with each 3 week cycle ]
    MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients who sign a written informed consent document and are able to comply with the study protocol for the duration of the study.
  2. Patients who have a histologically or cytologically confirmed diagnosis malignancy (patients with measurable or non-measurable disease) who have progressed following effective therapy or for which no effective therapy exists.
  3. Patients who are greater than or equal to 18 years of age.
  4. Patients who have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  5. Patients who have an estimated life expectancy of 3 months.
  6. Patients who have a normal cardiac ejection fraction, >50% estimated by 2 D Echocardiogram or MUGA.
  7. Patients who have adequate organ function as indicated by the following laboratory values obtained within 10 days prior to the first dose of SSG: Granulocytes>/=1,500 microliter, Platelets>/= 100,000 microliter, Hemoglobin >/=9.0 g/dL,Creatinine (Cr) </= 1.5 mg/dL, Bilirubin Normal limits, or <2.0 x ULN with liver metastases, Aspartate aminotransferase (AST) <2.5 * ULN or <5.0 * ULN with liver metastases, Alanine aminotransferase (ALT)<2.5 * ULN or <5.0 * ULN with liver metastases.

Exclusion Criteria:

  1. Patients on concurrent immunotherapy, including IFN therapy (prior therapy is allowed if >/= 4 months since immunotherapy).
  2. Patients who have received investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy, radiation therapy, chemotherapy, or had major surgery within 3 weeks of study enrollment
  3. Patients who have not recovered from acute toxicity of previous therapy prior to enrollment.
  4. Patients with medically uncontrolled cardiovascular illness, unstable angina, congestive heart failure, history of myocardial infarction, electrocardiogram (ECG) abnormalities suggestive of cardiac conduction delay (QTc >0.47 seconds), history of atrial fibrillation or flutter, or other serious clinically significant cardiac arrhythmia
  5. Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant.
  6. Pregnant or lactating women, and fertile women or men unless surgically sterile or using effective contraception; All female patients of childbearing potential or < 1 year postmenopausal must have a negative beta human chorionic gonadotropin (βhCG) pregnancy test at baseline and be practicing a medically acceptable method of birth control (oral contraceptives for at least 3 months, implantation of an intrauterine device at least 2 months, or barrier methods [e.g. vaginal diaphragm, vaginal sponge, or condom with spermicidal jelly]). These must be continued for 3 months after study initiation
  7. Patients who use daily glucocorticoids except for physiological replacement.
  8. Patients who are known to be positive for Hepatitis B surface antigen, Hepatitis C or human immunodeficiency virus (HIV).
  9. Patients with prior history of solid organ allografts or allogeneic bone marrow transplant.
  10. Patients who have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
  11. Patients who have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  12. Patient who have symptomatic or untreated central nervous system metastases.
  13. Patients taking the following medications will not be eligible: Amiodarone (Cordarone); Disopyramide (Norpace); Dofetilide (Tikosyn); Procainamide (Procanbid, Pronestyl); Quinidine (Quinaglute); Sotalol (Betapace); Erythromycin; Azithromycin (Z-pack), cont'd
  14. Clarithromycin (Biaxin); Pentamidine (Pentacarinat); Trimethoprim-sulfamethoxazole (Bactrim); Bepridil (Vascor); Phenothiazines-prochlorperazine (Compazine), promethazine (Phenergan), chlorpromazine (Thorazine) or any antipsychotic medication; Butyrophenones-Haloperidol (Haldol), cont'd
  15. Risperidone (Risperdal); Tricyclic or tetracyclic antidepressants-imipramine (Tofranil), amitriptyline (Elavil), desipramine (Norpramin), nortriptyline (Pamelor); Monoamine oxidase inhibitors; High dose methadone; Arsenic trioxide; Dolasetron (Anzemet); Any herbal preparations; or • Chronic need for colony stimulating factors (i.e., GM-CSF), erythropoietin use is permitted.
  16. Patients with a history of hypersensitivity to IFN a-2b or SSG or any of their components.

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): NCT00629200

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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
VioQuest Pharmaceuticals
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Principal Investigator: Aung Naing, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00629200    
Obsolete Identifiers: NCT01479309
Other Study ID Numbers: 2006-0354
NCI-2010-01525 ( Registry Identifier: NCI CTRP )
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Keywords provided by M.D. Anderson Cancer Center:
Advanced Malignancies
Solid Tumors
Renal Cell Carcinoma
Phase I Studies
Sodium Stibogluconate
Interferon Alpha-2b
Intron A
Additional relevant MeSH terms:
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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