Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers

Exclusion Criteria

• •Stage T1 disease without metastases
• •Abnormal laboratory values at screening within the following ranges:
• •Absolute neutrophil count ≤ 1.5 × 109/ L; Platelet count ≤ 100 × 109/ L
• •Leukocyte count ≤ 3 × 109/ L; Hemoglobin ≤ 80 g/ L; Serum creatinine ≥ 2.0 × the upper normal limit (UNL); Total bilirubin ≤ 1.5 × UNL; AST and ALT ≤ 3.0 × UNL
• •Fasting serum cholesterol ≤ 9.0 mmol/ L; Fasting serum triglycerides ≥ 5.0 mmol/L
• •Any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study
• •Other currently active malignancies
• •Currently taking any medications known to interfere with the metabolism of everolimus
• •Receiving anticoagulation with warfarin
• •A history of pulmonary hypertension or interstitial lung disease