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Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma
This study is ongoing, but not recruiting participants.
First Received: April 5, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: Case Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00311558
  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
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Cancer Kaposi's Sarcoma Lymphoma Multiple Myeloma Soft Tissue Sarcoma
Drug Information available for: Sodium stibogluconate Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tolerance, safety, and maximum tolerated dose at 1 week after each course [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: October 2005
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, 44195-5044
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Ernest C. Borden, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000449681, CASE-CCF-7509, CASE-CCF-1062
Study First Received: April 5, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00311558     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
stage IV melanoma
stage IV breast cancer
stage IV prostate cancer
stage IV colon cancer
stage IV rectal cancer
stage IV adult soft tissue sarcoma
stage III multiple myeloma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult T-cell leukemia/lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV mycosis fungoides/Sezary syndrome
stage IV small lymphocytic lymphoma
classic Kaposi sarcoma
AIDS-related Kaposi sarcoma
immunosuppressive treatment related Kaposi sarcoma
recurrent Kaposi sarcoma
refractory multiple myeloma
recurrent adult Burkitt lymphoma

Study placed in the following topic categories:
Mantle Cell Lymphoma
Lung Neoplasms
Lymphoma, Large-Cell, Anaplastic
Neuroepithelioma
Insulinoma
Breast Neoplasms
Ewing's Sarcoma
Aggressive Fibromatosis
Carcinoma
Waldenstrom Macroglobulinemia
Sarcoma
Lymphoma, Non-Hodgkin
Carcinoma, Non-Small-Cell Lung
Immunologic Factors
Desmoid Tumor
Lymphoma, Follicular
Sezary Syndrome
Lymphoblastic Lymphoma
Lymphoma, B-Cell
Leukemia
Sarcoma, Ewing's
Soft Tissue Sarcomas
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Ewing's Family of Tumors
Lymphomatoid Granulomatosis
Kidney Cancer
Pancreatic Islet Cell Tumors
Interferons
Hodgkin's Disease

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Antiprotozoal Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antiparasitic Agents
Antimony Sodium Gluconate
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Lymphoma
Interferon-alpha
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antiplatyhelmintic Agents
Growth Substances
Interferons
Anthelmintics
Antiviral Agents
Schistosomicides
Angiogenesis Inhibitors
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Lymphoproliferative Disorders
Interferon Alfa-2b

ClinicalTrials.gov processed this record on May 07, 2009