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
- To determine the dose-limiting toxicities and maximum tolerate dose of systemic
sorafenib tosylate in combination with regionally administered melphalan by isolated
limb infusion in patients with stage IIIB or IIIC intransit extremity melanoma.
- To characterize the safety and tolerability of this regimen in these patients.
- To assess the antitumor activity of this regimen, as evidenced by best overall response
and duration of response, in these patients.
- To characterize the duration of progression-free survival of these patients.
- To characterize the pharmacokinetics of melphalan.
- To assess alterations in selected gene and protein expression profiles following
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Douglas S. Tyler, MD
Duke Cancer Institute
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|