Everolimus(RAD001) For Advanced Renal Cell Carcinoma(RCC)Before Kidney Removal

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Baylor College of Medicine
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Gilad Amiel, Baylor College of Medicine
ClinicalTrials.gov Identifier:
First received: January 27, 2009
Last updated: October 25, 2012
Last verified: October 2012

January 27, 2009
October 25, 2012
April 2011
July 2016   (final data collection date for primary outcome measure)
Disease progression diagnosed by biopsy [ Time Frame: disease progression ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00831480 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Everolimus(RAD001) For Advanced Renal Cell Carcinoma(RCC)Before Kidney Removal
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.
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Cancer
Drug: everolimus
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.
Other Names:
  • RAD001
  • Afinitor
Active Comparator: 1
All subjects will take everolimus
Intervention: Drug: everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 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
18 Years and older
Contact: Sebrina Tello 713-798-8106 stello@bcm.edu
United States
Not Provided
Not Provided
Gilad Amiel, Baylor College of Medicine
Gilad Amiel
University of Texas Southwestern Medical Center
Principal Investigator: Gilad E. Amiel, MD Baylor College of Medicine
Baylor College of Medicine
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP