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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014