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A Phase II Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma, Renal Cancer

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Trial Information

A Phase II Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

- Participants will undergo a CT or ultrasound guided biopsy of an accessible tumor
lesion before beginning the study medication.

- Everolimus tablets will be taken orally once a day. Participants will undergo a
physical exam and will be asked questions about their general health and specific
questions about any problems they might be having. Photographs will be taken of the
tumor to assess the response to treatment. This will be done by a CT or MRI scan.
Blood tests will be performed every 4 weeks. In addition, blood for research purposes
will be done on day 1 of every other cycle. A urine test will be done every 4 weeks.

Inclusion Criteria:

- Patients must have at least one site of disease which in the opinion of the
investigator is safely accessible by CT guided biopsy or metastasectomy. Safely
accessible metastatic disease will be defined to include those lesions which are
palpable with no overlying viscera and are at least 2cm in size. Given the paucity
of subcutaneous lesions in RCC, lesions which are felt to be safe to biopsy will also
be allowed. These lesions include pleural-based tumors, peripheral liver lesions,
kidney lesions and bone lesions with exophytic soft tissue component. As with
palpable lesions, these other lesions should be at least 2cm in size with no
overlying viscera.

- At least one measurable site of disease, other than the biopsy site, according to
RECIST criterial that has not been previously irradiated. Th the patient has had
previous radiation to the marker lesion(s), there must be evidence of progression
since the radiation

- Metastatic renal carcinoma with histologic confirmation by the treating center of
either primary or a metastatic lesion. Non-clear cell histologies will be allowed

- 18 years of age or older

- Minimum of four weeks since any major surgery, completion of radiation, or completion
of all prior systemic anticancer therapy (adequately recovered from the acute
toxicities of any prior therapy)

- ECOG Performance status of 1 or less

- Adequate bone marrow, liver and renal function as outlined in the protocol

- Fasting serum cholesterol < 300mg/dL OR < 7.75 mmol/L AND fasting triglycerides < 2.5

- Life expectancy of greater than 6 months

Exclusion Criteria:

- Prior treatment with any investigation drug within the preceding 4 weeks

- Chronic treatment with systemic steroids or another immunosuppressive agent

- Patients should not receive immunization with attenuated live vaccines within one
week of study entry or during study period

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases. Treated brain
metastases will be allowed. Treated brain metastases are defined as having no
evidence of progression or hemorrhage after treatment and no ongoing requirement for
dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT)
during the screening period. Anticonvulsants (stable dose) are allowed. Treatment
for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS:
Gamma Knife, LINAC or equivalent) or a combination as deemed appropriate by the
treating physician. Patients with CNS metastases treated by neurosurgical resection
performed within 3 months prio to day 1 will be excluded.

- Other malignancies within the past 3 years except for adequately treated carcinoma of
the cervix or basal or squamous cell carcinomas of the skin

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study

- Uncontrolled diabetes mellitus as defined by a fasting serum > 1.5 x ULN

- A known history of HIV seropositivity.

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of everolimus

- Patients with active, bleeding diathesis or on systemic anticoagulation. Aspirin is

- Women who are pregnant or breast feeding, or women/men able to conceive and unwilling
to practice an effective method of birth control.

- Patients who have received prior treatment with an mTOR inhibitor.

- Patients with known hypersensitivity to everolimus or other rapamycins or to its

- History of noncompliance to medical regimens

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To prospectively validate the expression of phospho-Akt and phospho-S6 as predictive biomarkers of responsiveness to everolimus.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Daniel Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cancer
  • everolimus
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Duke University Medical CenterDurham, North Carolina  27710