| Exclusion Criteria: | 1) Patients receiving anticancer therapies within last 2 weeks or who have received radiation therapy within 3 weeks of study day 1
2) Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
3) Prior treatment with any investigational drug within the preceding 3 weeks
4) Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
5) Patients should not receive immunization with attenuated live vaccines within 2 weeks of study entry or during study period
6) Patients who have brain or leptomeningeal metastases that can not be controlled with radiotherapy or radioiodine treatment including patients who require glucocorticoids for brain or leptomeningeal metastases.
7) Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. Exceptions may be made by the PI for other low risk cancer diagnosis within the last 3 years.
8) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:New York Heart Association Class III or IV; unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrythmia or any other significat cardiac disease; severly imparied lung function; uncontrolled diabetes fasting serum >1.5xULN; active or uncontrolled severe infections; liver disease such as cirrhosis, chronic active or presistent hepatitis, positive screening hepatitis C test or history of HCV infection including those with a negative viral load test at baseline
9) A known history of HIV seropositivity
10) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome or small bowel resection)
11) Patients with an active, bleeding diathesis
12) Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to administration of RAD001)
13) Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
14) Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
15) History of noncompliance to medical regimens
16) Patients unwilling to or unable to comply with the protocol |