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Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

Thank you

Trial Information

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Disease progression diagnosed by biopsy

Outcome Time Frame:

disease progression

Safety Issue:


Principal Investigator

Gilad E. Amiel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

July 2016

Related Keywords:

  • Kidney Cancer
  • Renal cell carcinoma
  • Everolimus
  • Neoadjuvant
  • advanced kidney cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Baylor College of MedicineHouston, Texas  77030
Ut Southwestern Medical CenterDallas, Texas  75390