Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)
- Advanced (metastatic) RCC
- Histology: clear cell, papillary or chromophobe
- 3 out 6 risk factors (by MSKCC 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 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
- 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
- Collecting duct, medullary histologies or sarcomatoid differentiation.
- 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
- 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
- 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
- Known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its
- 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