IRB Number:

1260-03

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The purpose of this research study is:

• to learn the highest dose of a modified measles virus that can be given in the abdominal cavity of patients with recurrent ovarian cancer by using escalating doses of the virus in consecutive groups of patients without causing unacceptable side effects;



• to look at the side effects of the virus when administered in the abdominal cavity; and,



• to assess the virus' effects in the body using blood, urine, throat gargle specimen(s), and tissue samples.

The virus used in this study produces an active protein marker called CEA when it propagates. CEA is a protein, which is found in the blood of people with a variety of diseases, most notably cancer, and it has not been reported to cause disease. The longterm effects of inducing CEA in the blood are unknown. CEA can be measured in blood and used to follow the activity of the virus. MV-CEA is an investigational agent. It is not yet approved by the Food and Drug Administration (FDA) for treatment of cancer.

Who is Eligible to Participate in the Study?

Women with recurrent ovarian cancer may be eligible to participate in this research study.

What is Involved With this Study?

If you agree to take part in this study, you will need to have tests done to see if you can be in the study. These tests include:

• a complete physical exam during which the researchers will look at your past medical history and look at how you are doing now;


• measurement of your height and weight, blood pressure, temperature, and pulse;


• a chest x-ray to exclude the presence of tumor in your lungs;


• an electrocardiogram (EKG) to look at your heart function;


• CT scans or other x-ray scans to find and measure your tumor(s);


• blood tests as part of your regular medical care;


• blood tests just for this research study; and,


• a skin test (DTH) that is similar to an allergy test, where the researchers will use a needle to inject your skin to see how brisk your immune response is.

In this study, each 4-week period will be called a treatment 'cycle'. You will be admitted to the General Clinical Research Center (GCRC) at Saint Marys Hospital the evening before the first day of treatment and stay until the morning of Day 2 (two nights). Prior to each viral administration a saline lock (intravenous line) will be placed in the arm for safety purposes. A saline lock will allow us to administer medications intravenously if necessary, while you are getting treatment. Subsequent treatments will also be administered in the GCRC, but no overnight stay will be required. This will allow investigators to collect blood, urine, throat gargle specimen(s), and tissue samples for research purposes.

How long will the Study run?

If your cancer improves or does not get worse, you will be allowed to have up to 6 cycles of treatment on this study. After stopping study treatment, you will be asked to keep coming to the clinic for follow up unless your cancer worsens. From that point you will be followed on a yearly basis for up to 15 years so that the researchers can watch your health status.

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: 05/07/2008