IRB Number:

06-002299

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done:
-To find the highest dose of sorafenib that can be given without causing unacceptable bad side effects.
-To find out what effects (good and bad) sorafenib and CCI-779 have on a patient and the brain tumor.
-To compare patient's response to sorafenib and CCI-779 with laboratory studies of a patient's blood cells and tumor tissues.
-To look at sorafenib and CCI-779's ability to slow down the growth of the tumor.
A tumor has "switches" that turn on tumor cell growth and division. These two drugs are thought to prevent two of the main switch pathways in the tumor cells from working properly, which hopefully might prevent the cells from growing. Sorafenib and CCI-779 are experimental drugs not yet approved by the Food and Drug Administration.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with glioblastoma
-Prior treatment with 2 or less chemotherapy regimens
-At least 12 weeks since last radiation treatment
-No prior treatment with CCI-779 or sorafenib allowed

*More specific, detailed eligibility and/ or exclusion criteria are associated with this study.

What is Involved With this Study?

-Neurological and physical exams
-Blood tests
-Pregnancy test, if female of childbearing potential
-MRI or CT scans of the brain
-Chest x-ray
-ECG (electrocardiogram)
-Completion of daily pill and blood pressure diaries
-Medication given in pill form and once a week through a vein

How long will the Study run?

Patients will be in the study as long as the disease does not get worse, or until a patient has side effects that are unacceptable. How long a patient is in the study will depend on how they do with the drug and how the cancer acts. Even if patient stops taking the study drug, the research staff will still want to stay in contact.

Sponsor(s): North Central Cancer Treatment Group (NCCTG)

Study Activation: 05/31/2006

IRB Review and Approval Date: 04/13/2006

Study Type: Treatment

Projected Accrual: 96 patients

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Kurt Jaeckle, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 05/23/2008