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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 |
---|---|---|
Cancer |
Drug: 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: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00311558 |
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 |
Sezary syndrome Malignant mesenchymal tumor Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Kaposi sarcoma Ewing's sarcoma Lung Neoplasms Lymphoma, Large-Cell, Anaplastic Neuroepithelioma Rectal cancer Non-small cell lung cancer Insulinoma Breast Neoplasms |
Carcinoma Waldenstrom Macroglobulinemia B-cell lymphomas Sarcoma Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Aggressive fibromatosis Carcinoma, Non-Small-Cell Lung Lymphoma, Follicular Sezary Syndrome Lymphoma, B-Cell Lymphoma, large-cell Leukemia Burkitt's lymphoma Sarcoma, Ewing's |
Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Antineoplastic Agents Antiplatyhelmintic Agents Growth Substances Physiological Effects of Drugs Anthelmintics |
Angiogenesis Inhibitors Antiviral Agents Schistosomicides Pharmacologic Actions Neoplasms Antiparasitic Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |