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
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
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.
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
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
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
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
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
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