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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00565968 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may also make tumor cells more sensitive to melphalan. Giving sorafenib together with an isolated limb infusion of melphalan may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with an isolated limb infusion of melphalan in treating patients with stage III melanoma of the arm or leg.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: melphalan Drug: sorafenib tosylate Procedure: gene expression analysis Procedure: pharmacological study Procedure: protein expression analysis Procedure: western blotting |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Dose Escalation Trial to Evaluate Safety and Efficacy of Oral Sorafenib (Nexavar) With Regional Melphalan Via Normothermic Isolated Limb Infusion (ILI) in Patients With Intransit Extremity Melanoma |
Estimated Enrollment: | 22 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of sorafenib tosylate.
Patients receive oral sorafenib tosylate twice daily on days 1-14 and melphalan via isolated limb infusion into the upper or lower extremities on day 8.
Patients undergo tumor biopsies at baseline and in weeks 2 and 12 for gene expression analysis and western blot analysis. Patients also undergo blood sample collection periodically for pharmacokinetic analysis of melphalan.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary or recurrent extremity melanoma
Stage IIIB or IIIC disease
Bidimensionally measurable disease by caliper or radiological method
Must have identifiable target lesions for disease assessment
No known brain metastasis
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
No history of other malignancies, except for any of the following:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Jill Kleczko 646-227-2221 |
Principal Investigator: | Douglas S. Tyler, MD | Duke University |
Study ID Numbers: | CDR0000575427, DUMC-Pro00001344 |
Study First Received: | November 29, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00565968 |
Health Authority: | Unspecified |
stage III melanoma recurrent melanoma |
Melphalan Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Sorafenib Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |