IRB Number:

06-002790

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to:
-Add CCI-779 to the standard treatment temozolomide (TMZ) and radiation (RT), which is hoped to make the standard treatment better. CCI-779 helps to stop signals that cause tumors to grow.
-Test the safety of the CCI-779 when given in combination with TMZ or in combination with TMZ and RT.
-Find the highest safe dose of CCI-779, an investigational agent, to give with RT and TMZ, which can safely be given without causing bad side effects.
-See what effects (good and bad) it has on the patient and the cancer.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with Glioblastoma Multiforme (GBM)
-Greater than 1 week and less than 6 weeks since surgical resection or biopsy
-No prior chemotherapy for any brain tumor
-No prior radiation to brain

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

What is Involved With this Study?

-Medical exams
-Blood tests
-Pregnancy test if female of childbearing potential
-MRI or CT of the brain
-Brain tumor tissue collected previously during patient's surgery will be reviewed to confirm results.
-Radiation Therapy given Monday through Friday for 6 weeks
-Medication given through a vein and in pill form

How long will the Study run?

Patients will be in the study for as long as the disease does not get worse. The treatment lasts for about 8-9 months, if no serious side effects have occurred and if there is no sign that the disease is getting worse. After the patient is finished with all of the treatment, the study doctor will ask the patient to visit the office for follow-up exams for the next 10 years.

Sponsor(s): North Central Cancer Treatment Group

Study Activation: 06/30/2006

IRB Review and Approval Date: 06/08/2006

Study Type: Treatment

Projected Accrual: 46 patients

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

Principal Investigator: Jann Sarkaria, 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

Last updated: 10/19/2009