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Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
This study is currently recruiting participants.
Verified by University of Chicago, April 2009
First Received: September 12, 2007   Last Updated: April 7, 2009   History of Changes
Sponsor: University of Chicago
Collaborator: Novartis
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00529802
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: RAD001
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • to determine whether high uptake on FDG-PET is associated with tumor shrinkage [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to determine whether a change in FDG-PET in the context of RAD001 therapy is associated with tumor shrinkage [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
high uptake of FDG-PET
Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
B: Experimental
low uptake of FDG-PET
Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529802

Contacts
Contact: Walter Stadler, MD 773-702-4150 wstadler@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Beth Manchen, RN     773-702-4135     emanchen@medicine.bsd.uchicago.edu    
Contact: Dale Rush     773-834-0669     drush@medicine.bsd.uchicago.edu    
Oncology/Hematology Associates Recruiting
Peoria, Illinois, United States, 61615
Contact: Sachdev Thomas, MD            
United States, Massachusetts
Beth Israel Deaconess Med Ctr Recruiting
Boston, Massachusetts, United States, 02215
Contact: David McDormatt, MD            
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Joel Picus, MD            
United States, North Carolina
The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kimryn Rathmell, MD, PhD            
Sponsors and Collaborators
University of Chicago
Novartis
Investigators
Principal Investigator: Walter Stadler, MD University of Chicago
  More Information

No publications provided

Responsible Party: The University of Chicago ( Walter Stadler, M.D. )
Study ID Numbers: 15599B
Study First Received: September 12, 2007
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00529802     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
metastatic
renal
cell
carcinoma
cancer

Additional relevant MeSH terms:
Everolimus
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010