- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00529802
Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
March 27, 2018 updated by: University of Chicago
An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Peoria, Illinois, United States, 61615
- Oncology/Hematology Associates
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Med Ctr
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Everolimus (RAD001) 10mg daily
All patients were to receive 10mg everolimus (RAD001) daily.
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take 2 tablets of RAD001 once a day by mouth (10 mg per day)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative Tumor Size Change Following 8 Weeks of Therapy.
Time Frame: 8 weeks
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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.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in FDG-PETUptake Following 2 Weeks of Therapy
Time Frame: 2 weeks
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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.
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
September 12, 2007
First Submitted That Met QC Criteria
September 12, 2007
First Posted (ESTIMATE)
September 14, 2007
Study Record Updates
Last Update Posted (ACTUAL)
April 25, 2018
Last Update Submitted That Met QC Criteria
March 27, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Everolimus
Other Study ID Numbers
- 15599B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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