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

Completed · Phase 1

Conditions studied: Advanced Cancer, Solid Tumors

In brief

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.

Key facts

Study ID

NCT00629200

Run by

M.D. Anderson Cancer Center

People needed

33

Starts

2006-09-13

Expected to finish

2010-02-10

Last updated by the study team

2018-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of New Mexico — Albuquerque, New Mexico, United States
• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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