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

A Pilot Study of Neo-Adjuvant Everolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy - Analysis of Serum and Tissue Biomarkers

This study will gather data on potential biomarkers in the treatment of advanced renal cell carcinoma (kidney cancer) and investigate their use as indicators of disease response. The results could eventually enable doctors to match levels of therapy to levels of biomarker on an individual basis and to increase the chance of disease response in patients. This study will also test a new paradigm in the treatment approach of advanced kidney cancer by using the drug everolimus in a neo-adjuvant setting, with the overarching goal of decreasing cancer recurrence rates and improving patient outcomes and survival.

Inclusion Criteria:

• At least 18 years of age and capable of giving informed consent
• Radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T3b, T4, or any stage T with N1/ 2 and/ or metastatic disease
• Having a nephrectomy and willing to have a kidney biopsy
• ECOG score 0 or 1
• Clear cell histology
• Negative for HIV, Hepatitis B, and Hepatitis C
• Negative pregnancy test for women of child-bearing potential

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