Clinical trial NCT00529802: Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
Official title: An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: metastatic
renal
cell
carcinoma
cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Relative Tumor Size Change Following 8 Weeks of Therapy.
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent Change in FDG-PETUptake Following 2 Weeks of Therapy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Oncology/Hematology Associates
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Med Ctr
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of Chicago
name: Walter Stadler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 10.