|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00498979 |
Purpose
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 dacarbazine, 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 dacarbazine in treating patients with advanced melanoma or other cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Melanoma |
Biological: recombinant interferon alfa-2b Drug: cisplatin Drug: sodium stibogluconate Drug: dacarbazine Drug: vinblastine |
Phase I |
| Study Type: | Interventional |
| Study Design: | 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 Followed by Cisplatin, Vinblastine and Dacarbazine for Patients With Melanoma or Malignancies Potentially Responsive to SSG and/or Interferons |
| Enrollment: | 22 |
| Study Start Date: | May 2007 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: recombinant interferon alfa-2b
recombinant interferon alfa-2b
|
Biological: recombinant interferon alfa-2b
recombinant interferon alfa-2b
Other Name: IFN 2b
Drug: cisplatin
recombinant interferon alfa-2b
Other Name: CDDP
Drug: sodium stibogluconate
sodium stibogluconate
Other Name: sodium stibogluconate
Drug: dacarbazine
dacarbazine
Other Name: DTIC
Drug: vinblastine
vinblastine
Other Name: VBL
|
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.
Eligibility| 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:
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Ernest C. Borden, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00498979 History of Changes |
| Other Study ID Numbers: | CASE3Y06, P30CA043703 |
| Study First Received: | July 10, 2007 |
| Last Updated: | January 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV melanoma adult anaplastic astrocytoma adult diffuse astrocytoma adult glioblastoma adult giant cell glioblastoma adult pilocytic astrocytoma adult brain stem glioma adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma |
adult subependymoma adult anaplastic oligodendroglioma adult oligodendroglioma mixed gliomas recurrent adult brain tumor recurrent melanoma adult gliosarcoma adult subependymal giant cell astrocytoma adult pineal gland astrocytoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Antimony Sodium Gluconate Cisplatin Dacarbazine |
Vinblastine 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 |