Melanoma Clinical Trial
Official title:
Phase 1 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma
This phase I trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temosirolimus may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of temsirolimus when administered with sorafenib
in patients with metastatic, recurrent, or unresectable melanoma.
II. To determine the safety and toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To Determine the population pharmacokinetics of this regimen in these patients.
II. To correlate tumor and blood biomarkers with clinical outcome in patients treated with
this regimen.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II,
open-label study (2005-0215).
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and oral sorafenib
once or twice daily on days 1-28. Treatment course repeats every 28 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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