Everolimus (RAD001) For Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal
Condition: Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: everolimus
Intervention description: 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.
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal cell carcinoma; Everolimus; Neoadjuvant; advanced kidney cancer

Summary:

      The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if
      Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal
      cell carcinoma - RCC).

      Since 2002, Everolimus has been studied in more than 2500 patients with various types of
      cancer as a single agent (a drug that is used alone to treat the cancer) or in combination
      with a number of well known anticancer therapies. Various studies, in animals such as in mice
      with cancer and in humans with cancer have shown that Everolimus can slow the growth of
      cancer.

      Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to
      remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed
      at the same dose.
    

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