Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: All subjects will take everolimus

everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
Eligibility criteria:
Inclusion Criteria:

Advanced (metastatic) RCC
Histology: clear cell, papillary or chromophobe
3 out 6 risk factors (by Memorial Sloan Kettering Cancer Center criteria and one additional criterion: multiple sites of metastasis) or not candidates for or refuse sunitinib.
Must have at least one measurable metastatic site according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria that has not been previously irradiated.
Must be deemed surgical candidates for cytoreductive nephrectomy by the urologist.
Age 18 years of age or older
Eastern Cooperative Oncology Group (EGOG) PS 0-2
Adequate bone marrow function
Adequate liver function as shown by:
Adequate renal function
Fasting serum cholesterol AND fasting triglycerides within normal limits
Signed informed consent

Exclusion Criteria:

Collecting duct, medullary histologies or sarcomatoid differentiation.
Central Nervous System (CNS) or leptomeningeal metastases.
Inappropriate candidates for cytoreductive nephrectomy or who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
severely impaired lung function
uncontrolled diabetes
active (acute or chronic) or uncontrolled severe infections
liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Ineligible for cytoreductive nephrectomy
Current or prior systemic anticancer therapies (including chemotherapy, antibody based therapy, or investigational drugs)
Other malignancies within the past 3 years except for localized carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or localized prostate cancer with Gleason Score less than 7 treated with radiation or surgery and no evidence of progression.
Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of enrollment
Anticipated major surgery (other than CN) during the course of the study
A known history of HIV seropositivity
Hepatitis C seropositivity
Chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
Immunization with attenuated live vaccines within one week of study entry or during study period
Known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients
Impairment of gastrointestinal function or gastrointestinal disease
Active, bleeding diathesis
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
History of noncompliance to medical regimens
Unwilling to or unable to comply with the protocol including mandated biopsies