Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer

The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.

Inclusion Criteria:

• Metastatic renal cancer refractory to sorafenib or sunitinib therapy
• At least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
• 18 years of age or older
• Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy.
• World Health Organization (WHO) performance status <= 2
• Adequate bone marrow function
• Adequate liver function
• Adequate creatinine clearance
• Signed informed consent

Exclusion Criteria:

• Prior treatment with any investigational drug within the previous 4 weeks
• Chronic treatment with systemic steroids or another immunosuppressive agent
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
• Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• A known history of HIV seropositivity
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
• Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment
• Patients who have received prior treatment with an mTOR inhibitor.
• Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
• History of noncompliance to medical regimens
• Patients unwilling to or unable to comply with the protocol