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

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.

Condition Intervention Phase
Kidney Cancer
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Disease progression diagnosed by biopsy [ Time Frame: disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
All subjects will take everolimus
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

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831480

Contact: Sebrina Tello 713-798-8106 stello@bcm.edu

United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: James Brugarlos, MD, PhD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Sub-Investigator: Guru Sonpavde, MD         
Sponsors and Collaborators
Gilad Amiel
University of Texas Southwestern Medical Center
Principal Investigator: Gilad E. Amiel, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Gilad Amiel, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00831480     History of Changes
Other Study ID Numbers: H-23409 
Study First Received: January 27, 2009
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Renal cell carcinoma
advanced kidney cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016