Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

Inclusion Criteria

• Patients must have at least one site of disease which in the opinion of the investigator is safely accessible by CT guided biopsy or metastasectomy. Safely accessible metastatic disease will be defined to include those lesions which are palpable with no overlying viscera and are at least 2cm in size. Given the paucity of subcutaneous lesions in RCC, lesions which are felt to be safe to biopsy will also be allowed. These lesions include pleural-based tumors, peripheral liver lesions, kidney lesions and bone lesions with exophytic soft tissue component. As with palpable lesions, these other lesions should be at least 2cm in size with no overlying viscera.
• At least one measurable site of disease, other than the biopsy site, according to RECIST criterial that has not been previously irradiated. Th the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
• Metastatic renal carcinoma with histologic confirmation by the treating center of either primary or a metastatic lesion. Non-clear cell histologies will be allowed
• 18 years of age or older
• Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
• ECOG Performance status of 1 or less
• Adequate bone marrow, liver and renal function as outlined in the protocol
• Fasting serum cholesterol 1.5 x ULN
• A known history of HIV seropositivity.
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
• Patients with active, bleeding diathesis or on systemic anticoagulation. Aspirin is permitted.
• Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control.
• Patients who have received prior treatment with an mTOR inhibitor.
• Patients with known hypersensitivity to everolimus or other rapamycins or to its excipients.
• History of noncompliance to medical regimens