Study to Evaluate Sodium Stibogluconate With Interferon Alpha-2b

This study has been withdrawn prior to enrollment.
(Pharmaceutical sponsor terminated study.)
Sponsor:
Collaborator:
VioQuest Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01479309
First received: November 21, 2011
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

The goal of this clinical research study is to expand the research following finding the highest tolerable dose of sodium stibogluconate combined with interferon alfa-2b in the treatment of patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for this type of cancer.


Condition Intervention Phase
Advanced Cancer
Solid Tumors
Drug: Sodium Stibogluconate
Drug: Interferon Alpha-2b
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIa, 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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


Enrollment: 0
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Primary objectives:

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 objective:

  • 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.

Treatment:

During Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5. On Days 8-12, you will be given sodium stibogluconate once a day by vein, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 8, 10, and 12. For every cycle after Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5 and 8-12, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 1, 3,5, 8, 10, and 12. Treatment cycles will last about 3 weeks (2 weeks on treatment, followed by 1 week off treatment). After Cycle 1, you will be scheduled to return to the clinic in 10 days to receive treatment for Cycle 2, which will follow in the same manner as Cycle 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479309

Sponsors and Collaborators
M.D. Anderson Cancer Center
VioQuest Pharmaceuticals
Investigators
Principal Investigator: Aung Naing, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01479309     History of Changes
Other Study ID Numbers: 2006-0354 IIa, 2006-0354
Study First Received: November 21, 2011
Last Updated: November 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Malignancies
Solid Tumors
Melanoma
Renal Cell Carcinoma
Phase I Studies
Sodium Stibogluconate
Interferon Alpha-2b
Intron A
SSG

Additional relevant MeSH terms:
Neoplasms
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antimony Sodium Gluconate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Antiprotozoal Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014