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

NCT00629200 | Completed Phase 1

• 2 other identifiers: 2006-0354NCI-2010-01525
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Cancer; Solid Tumors

Keywords

Advanced Malignancies; Solid Tumors; Melanoma; Renal Cell Carcinoma; Phase I Studies; Sodium Stibogluconate; Interferon Alpha-2b; Intron A; SSG

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of SSG in combination with IFN alpha2b

  MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.

  Continuous assessment with each 3 week cycle

Study Arms (1)

SSG + Intron A

EXPERIMENTAL

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; Drug: Interferon Alpha-2b

Interventions

Sodium Stibogluconate DRUG

400 mg/m\^2 IV daily on days 1-5.

Also known as: SSG

SSG + Intron A

Interferon Alpha-2b DRUG

3x10\^6 units subcutaneously three times weekly

Also known as: Intron A

SSG + Intron A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• VioQuest Pharmaceuticals: collaborator

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell

Interventions

Antimony Sodium Gluconate; Introns

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: September 13, 2006
• Primary Completion: February 10, 2010
• Study Completion: February 10, 2010
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

US (2)