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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00498979 |
RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as cisplatin, vinblastine, and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sodium stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and temozolomide in treating patients with advanced melanoma or other cancer.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors Melanoma (Skin) |
Drug: cisplatin Drug: recombinant interferon alfa-2b Drug: sodium stibogluconate Drug: temozolomide Drug: vinblastine Procedure: gene expression analysis Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase I |
MedlinePlus related topics: | Cancer Melanoma |
ChemIDplus related topics: | Cisplatin Temozolomide Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Sodium stibogluconate Vinblastine Vinblastine sulfate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b Followed by Cisplatin, Vinblastine and Temozolomide for Patients With Melanoma or Malignancies Potentially Responsive to SSG and/or Interferons |
Estimated Enrollment: | 24 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Cohorts of 6 patients receive escalating doses of sodium stibogluconate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which dose-limiting toxicity occurs (i.e., no more than 1 patient at a given dose experiences DLT).
Patients undergo blood sample collection periodically for immunological and pharmacokinetic studies. Samples are analyzed for serum soluble gene products and protein tyrosine phosphatase inhibition.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma or other malignancies
Gliomas or controlled CNS metastasis allowed
Patients must have measurable or evaluable disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Pregnant or lactating women and fertile women or men unless surgically sterile or using effective contraception
Culture positive acute infections requiring antibiotics within the past 14 days
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Patients taking the following medications will not be eligible:
Case Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Ernest C. Borden, MD | The Cleveland Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000557420, CASE-3Y06 |
First Received: | July 10, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00498979 |
Health Authority: | Unspecified |
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