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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529802
• Other study ID #: 15599B
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2007
• Last updated: March 27, 2018
• Start date: September 2007
• Est. completion date: July 2010

Study information

• Verified date: March 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Oncology/Hematology Associates	Peoria	Illinois
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen JL, Appelbaum DE, Kocherginsky M, Cowey CL, Rathmell WK, McDermott DF, Stadler WM. FDG-PET as a predictive biomarker for therapy with everolimus in metastatic renal cell cancer. Cancer Med. 2013 Aug;2(4):545-52. doi: 10.1002/cam4.102. Epub 2013 Jul 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Tumor Size Change Following 8 Weeks of Therapy.	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.	8 weeks
Secondary	Percent Change in FDG-PETUptake Following 2 Weeks of Therapy	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.	2 weeks

External Links

•   Study results publication available through PMC