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Sponsored by: |
Case Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00311558 |
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 |
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Cancer |
Biological: recombinant interferon alfa-2b Drug: sodium stibogluconate |
Phase I |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including, but not limited to, any of the following:
PATIENT CHARACTERISTICS:
No history of any of the following:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195-5044 |
Study Chair: | Ernest C. Borden, MD | The Cleveland Clinic |
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 |
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 |
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 |
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 |