Kidney Cancer Clinical Trial
Official title:
Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)
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.
Everolimus has significantly improved outcomes following prior therapy. This study is a biomarker driven Phase II trial that will assess the activity of everolimus as first-line therapy for renal cell carcinoma. Following initial kidney tumor biopsy, everolimus is administered for 3-5 weeks before cytoreductive nephrectomy and everolimus is then resumed and continued until tumor progression or intolerable toxicities. Any correlation of tumor tissue biomarker changes from initial biopsy to nephrectomy specimen with long-term progression-free survival will be determined. This trial may enable the identification of factors predictive of significant benefit from everolimus administered as first-line therapy by employing the neoadjuvant therapy paradigm. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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