Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma

NCT00311558 | Terminated Phase 1 DMC

• 5 other identifiers: CASE-CCF-7059P30CA043703CASE-CCF-7509CASE-CCF-1062CASE 2Y06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells. Giving sodium stibogluconate together with interferon may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon in treating patients with advanced solid tumors, lymphoma, or myeloma.

Conditions

Cancer

Keywords

stage IV melanoma; stage IV adult soft tissue sarcoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Tolerance, safety, and maximum tolerated dose at 1 week after each course

  3 years

Study Arms (1)

SSG & INF

EXPERIMENTAL

1 arm study: SSG \& interferon

Biological: recombinant interferon alfa-2b; Drug: sodium stibogluconate; Drug: SSG & interferon

Interventions

recombinant interferon alfa-2b BIOLOGICAL

SSG x 5 week

Also known as: Sodium Stibocluconate

SSG & INF

sodium stibogluconate DRUG

SSG \& IFN

SSG & INF

SSG & interferon DRUG

1 arm study with SSG \& interferon

Also known as: Sodium Stiboglucante

SSG & INF

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignancy, including, but not limited to, any of the following: * Renal cell carcinoma * Melanoma * Kaposi's sarcoma * Breast, prostate, colorectal, or lung adenocarcinoma * Bone and soft tissue sarcomas * Lymphoma * Myeloma * Tumors of neuroendocrine and endothelial cell origin * Stage IV disease * Refractory disease, resistant to established treatments, or no effective treatment available * Measurable or evaluable disease * CNS metastases allowed if no prior definitive therapy within the past 3 months and no glucocorticoids required PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine \< 1.0 times upper limit of normal (ULN) * Creatinine clearance ≥ 60 mL/min * Bilirubin \< 1.5 times ULN * AST/ALT \< 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No history of any of the following: * Atrial fibrillation, atrial flutter, or other serious arrhythmia (excluding asymptomatic atrial and ventricular premature complexes) * Congestive heart failure currently requiring treatment * Angina pectoris * Other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease) * No baseline ECG abnormalities suggestive of cardiac conduction delay, i.e., 1° or greater atrio-ventricular block and/or complete or incomplete (QRS \> 120 ms) bundle branch block, or repolarization abnormalities (i.e., QTc ≥ 0.48 sec) * No systemic infections requiring antibiotics within the past 14 days * No known hepatitis B surface antigen positivity * Psychologically prepared to participate in study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior interferon (IFN) therapy and/or ≤ 400 million units of IFN * At least 3 weeks since prior major surgery * At least 3 weeks since prior radiation therapy or chemotherapy * No prior solid organ allografts or allogeneic bone marrow transplantation * No concurrent daily glucocorticoids except for physiological replacement * No other concurrent medications known to prolong QT interval

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma; Sarcoma

Interventions

Introns; Antimony Sodium Gluconate; Interferons

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ernest C. Borden, MD

  The Cleveland Clinic

  STUDY CHAIR

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: April 5, 2006
• First Posted: April 6, 2006
• Study Start: October 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

US (1)