Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: RAD001
Intervention description: take 2 tablets of RAD001 once a day by mouth (10 mg per day)
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; renal; cell; carcinoma; cancer

Summary:

      The purpose of this study is to learn if PET scanning can predict the degree of tumor
      shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic renal cancer refractory to sorafenib or sunitinib therapy

          -  At least one measurable site of disease according to RECIST criteria that has not been
             previously irradiated.

          -  18 years of age or older

          -  Minimum of two weeks since any major surgery, completion of radiation, or completion
             of all prior standard systemic anticancer therapy and adequately recovered from the
             acute toxicities of any prior therapy.

          -  World Health Organization (WHO) performance status <= 2

          -  Adequate bone marrow function

          -  Adequate liver function

          -  Adequate creatinine clearance

          -  Signed informed consent

        Exclusion Criteria:

          -  Prior treatment with any investigational drug within the previous 4 weeks

          -  Chronic treatment with systemic steroids or another immunosuppressive agent

          -  Uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases

          -  Patients who have a history of another primary malignancy ≤ 3 years, with the
             exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix

          -  Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study

          -  A known history of HIV seropositivity

          -  Impairment of gastrointestinal function or gastrointestinal disease that may
             significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
             nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)

          -  Patients with an active, bleeding diathesis or on oral anti-vitamin K medication

          -  Women who are pregnant or breast feeding, or women/men able to conceive and unwilling
             to practice an effective method of birth control from enrollment through 6 months
             following the end of treatment

          -  Patients who have received prior treatment with an mTOR inhibitor.

          -  Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins
             (sirolimus, temsirolimus) or to its excipients

          -  History of noncompliance to medical regimens

          -  Patients unwilling to or unable to comply with the protocol