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

Primary Purpose

Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa-2b
sodium stibogluconate
SSG & interferon
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring stage IV melanoma, stage IV adult soft tissue sarcoma, recurrent melanoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SSG & INF

Arm Description

1 arm study: SSG & interferon

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2006
Last Updated
January 24, 2018
Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00311558
Brief Title
Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma
Official Title
Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Confirm the tolerance, safety, and maximum tolerated dose of sodium stibogluconate (SSG) in combination with interferon alfa-2b in patients with advanced solid tumors, lymphoma, or myeloma. Secondary Quantify the effect of SSG on interferon alfa-2b-induced gene modulation and signal transduction pathways by measurement of the serum-soluble gene products β-2 microglobulin, immune serum globulin 15, and neopterin. Define the effectiveness of SSG in inhibiting the protein tyrosine phosphatases src homology proteins (SHP)-1 and SHP-2 assayed from peripheral blood leukocytes of patients receiving SSG in combination with interferon alfa-2b. Define pharmacokinetics of SSG in serum at escalating doses. Assess clinical response to the combination of SSG and interferon alfa-2b. OUTLINE: This is an open-label, dose-escalation study of sodium stibogluconate (SSG). Patients receive SSG IV over 15 minutes on days 1, 15-19, and 22-26 and interferon alfa-2b subcutaneously daily on days 8-12 and 15-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of SSG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
stage IV melanoma, stage IV adult soft tissue sarcoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSG & INF
Arm Type
Experimental
Arm Description
1 arm study: SSG & interferon
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa-2b
Other Intervention Name(s)
Sodium Stibocluconate
Intervention Description
SSG x 5 week
Intervention Type
Drug
Intervention Name(s)
sodium stibogluconate
Intervention Description
SSG & IFN
Intervention Type
Drug
Intervention Name(s)
SSG & interferon
Other Intervention Name(s)
Sodium Stiboglucante
Intervention Description
1 arm study with SSG & interferon
Primary Outcome Measure Information:
Title
Tolerance, safety, and maximum tolerated dose at 1 week after each course
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest C. Borden, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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