Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Everolimus (RAD001) 10mg daily	RAD001	All patients were to receive 10mg everolimus (RAD001) daily.

Primary Outcome Measures

Name	Time	Method
Relative Tumor Size Change Following 8 Weeks of Therapy.	8 weeks	The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.

Secondary Outcome Measures

Name	Time	Method
Percent Change in FDG-PETUptake Following 2 Weeks of Therapy	2 weeks	The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans.

Locations (5): Oncology/Hematology Associates
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Peoria, Illinois, United States
University of Chicago
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Chicago, Illinois, United States
Beth Israel Deaconess Med Ctr
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Boston, Massachusetts, United States
Washington University
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Saint Louis, Missouri, United States
The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
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Chapel Hill, North Carolina, United States