IRB Number:

06-004440

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to:

• Test the safety of the measles virus, MV-CEA, and see what effects (good and bad) it has on you and your brain cancer


• Find the highest dose of MV-CEA that can be given without causing bad side effects


• Find out how the tumor and your cells respond to the MV-CEA


• Test levels of CEA in your blood at different doses of MV-CEA


• Test for the presence of measles virus in your body after you are given MV-CEA

Who is Eligible to Participate in the Study?

Men or women 18 years of age and older who have a kind of brain cancer called glioblastoma multiforme (GBM) that has returned after treatment, or has not responded to treatment.

What is Involved With this Study?

The treatment schedule you follow will depend on the dose level of MV-CEA you are receiving and how well you and other patients on the study are tolerating the treatment. The first patients in the study will be assigned to group I. On day 1 of the study, patients in treatment Group I will have surgery to remove their tumor after their diagnosis has been confirmed. The MV-CEA will be injected directly into the area where the tumor was removed. It will take about 10 minutes to inject all of the MV-CEA. The first three patients of this group will receive the lowest dose of MV-CEA. Each succeeding three to six patients will receive progressively higher doses of MV-CEA, until bad side effects are observed. This will determine the maximum tolerable dose. The dose you receive will depend upon when you enter this study. You will be seen again on days 3, 14 and 28 for a physical exam, blood tests, tumor measurements and tests for the presence of the measles virus. This will be done by a mouth swab or a urine test in the General Clinical Research Center.

How long will the Study run?

Participants will receive treatment in this study until their disease gets worse. Follow-up will be done for up to 15 years after study registration.

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

Last updated: 05/27/2008