Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Disease progression diagnosed by biopsy
disease progression
Yes
Gilad E. Amiel, MD
Principal Investigator
Baylor College of Medicine
United States: Food and Drug Administration
H-23409
NCT00831480
April 2011
July 2016
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |