Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by The Cleveland Clinic.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
The Cleveland Clinic
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00311558
First received: April 5, 2006
Last updated: March 29, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Biological: recombinant interferon alfa-2b Drug: sodium stibogluconate Drug: SSG & interferon |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma |
Resource links provided by NLM:
Further study details as provided by The Cleveland Clinic:
Primary Outcome Measures:
- Tolerance, safety, and maximum tolerated dose at 1 week after each course [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SSG & INF
SSG & interferon
|
Biological: recombinant interferon alfa-2b
SSG x 5 week
Other Name: Sodium Stibocluconate
Drug: sodium stibogluconate
SSG & IFN
Other Name: Sodium Stibogluconate
Drug: SSG & interferon
1 arm study with SSG & interferon
Other Name: Sodium Stiboglucante
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311558
Locations
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
The Cleveland Clinic
Investigators
| Study Chair: | Ernest C. Borden, MD | The Cleveland Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ernest C.Borden, M.D., Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00311558 History of Changes |
| Other Study ID Numbers: | CASE-CCF-7509, P30CA043703, CASE-CCF-7509, CASE-CCF-1062 |
| Study First Received: | April 5, 2006 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Cleveland Clinic:
|
stage IV melanoma stage IV adult soft tissue sarcoma recurrent melanoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Reaferon Antimony Sodium Gluconate Antiviral Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Antiprotozoal Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on June 18, 2013