Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
VioQuest Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00629200
First received: February 25, 2008
Last updated: November 21, 2011
Last verified: November 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Cancer Solid Tumors |
Drug: Sodium Stibogluconate Drug: Interferon Alpha-2b |
Phase 1 |
| 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 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 |
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: Continuous assessment with each 3 week cycle ] [ Designated as safety issue: Yes ]MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.
| Enrollment: | 33 |
| 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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who sign a written informed consent document and are able to comply with the study protocol for the duration of the study.
- 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.
- Patients who are greater than or equal to 18 years of age.
- Patients who have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Patients who have an estimated life expectancy of 3 months.
- Patients who have a normal cardiac ejection fraction, >50% estimated by 2 D Echocardiogram or MUGA.
- 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:
- Patients on concurrent immunotherapy, including IFN therapy (prior therapy is allowed if >/= 4 months since immunotherapy).
- 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
- Patients who have not recovered from acute toxicity of previous therapy prior to enrollment.
- 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
- Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant.
- 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
- Patients who use daily glucocorticoids except for physiological replacement.
- Patients who are known to be positive for Hepatitis B surface antigen, Hepatitis C or human immunodeficiency virus (HIV).
- Patients with prior history of solid organ allografts or allogeneic bone marrow transplant.
- Patients who have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- 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.
- Patient who have symptomatic or untreated central nervous system metastases.
- 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
- 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
- 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.
- Patients with a history of hypersensitivity to IFN a-2b or SSG or any of their components.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629200
Locations
| 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
Investigators
| Principal Investigator: | Aung Naing, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00629200 History of Changes |
| Other Study ID Numbers: | 2006-0354 |
| Study First Received: | February 25, 2008 |
| Last Updated: | November 21, 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 May 16, 2013