Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Fluorodeoxyglucose F18

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

All patients were to receive 10mg everolimus (RAD001) daily.

take 2 tablets of RAD001 once a day by mouth (10 mg per day)

RAD001

Walter Stadler, MD

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.

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

An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer

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.

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.

Novartis

University of Chicago

These results are based on n=56 patients who were evaluable for toxicity (all patients started treatment but 4 had missing data).

All patients were to receive 10mg everolimus (RAD001) daily.

These results are based on n=56 patients who were evaluable for toxicity.

Age, Continuous

Sex: Female, Male

Clear Cell

Papillary Cell

Chromophobe

Unclassified/Other

Tumor Type

Low Uptake (avgSUVmax<=4)

High Uptake (avgSUVmax>4)

The standardized uptake value (SUV) was calculated for each FDG-PET scan. The average of the maximum SUV (SUVmax) across all lesions (aveSUVmax) on the baseline scan was used to classify patients into low- and high-uptake. Low uptake group was defined as avgSUVmax \<=4, and high uptake group was defined as avgSUVmax \> 4.

Average SUVmax

Relative changes in tumor size were log-transformed to satisfy the normality assumption.

Low uptake FDG-PET is defined as avgSUVmax\<=4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the "standardized uptake value") .

Low Uptake

High uptake of FDG-PET defined as avgSUVmax\>4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the "standardized uptake value") .

High Uptake

50 patients were evaluable for response and had a baseline FDG-PET scan.

Relative Tumor Size Change Following 8 Weeks of Therapy.

The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.

Patients who had two FDG-PET scans completed, one at baseline and one after 2 weeks of treatment, were evaluable for secondary outcome.

Patients Evaluable for Secondary Outcome

Patients evaluable for tumor response at 8 weeks who also had both the baseline and 2-week FDG-PET scans.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial