Finding studies
Finding studies
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Lead
Gustave Roussy, Cancer Campus, Grand Paris
OBJECTIVES: Primary * Determine the safety profile and the maximum tolerated dose of sorafenib tosylate and temozolomide in patients with stage III-IV melanoma. (Phase I) * Evaluate progression-free survival at 12 weeks. (Phase II) Secondary * Evaluate tumor response according to RECIST criteria. * Evaluate overall and progression-free survival. * Evaluate the effect of treatment on tumor vascularization. * Compare the pharmacokinetic profile of temozolomide with and without sorafenib tosylate. * Evaluate the number and the role of lymphocytes. * Correlate tumor response rate with BRAF mutation status. * Correlate response rate with MGMT activity. * Compare the efficacy of genomics and proteomics as a means of discovery of serum biomarkers. * Study the prognostic and predictive value of circulating endothelial cells and circulating endothelial progenitors. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients receive oral sorafenib tosylate twice daily on days 1-28 (days 8-28 of course 1) and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with accessible tumors (cutaneous or sub-cutaneous) undergo biopsies at baseline and day 28 for analysis of BRAF mutations and MGMT expression.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
