IRB Number:

06-006992

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Patients are being asked to take part in this research study because they have been diagnosed with metastatic melanoma and they are a candidate for plasma therapy. This treatment uses an antibody taken from a patient that appears to activate the immune system against melanoma.
The study drug is a small sample of the patient's plasma containing the antibody B7-DC XAb. The antibody was discovered for its ability to stimulate the immune system in a way in which the body would become aware of the presence of the cancer. The molecule will bind receptors on the surface of immune cells and stimulate anti-tumor immunity. The researchers can measure the results of this change in the peripheral blood (blood from a vein) as well as look to see if this will reduce the size of the tumors.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with metastatic melanoma and patient is a candidate for plasma therapy

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

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:

Before beginning the study
Before starting the study, patients will have a complete medical history and physical exam along with standard blood tests and other tests that the researcher might feel are needed. Patients would likely have the same tests and procedures if they were having chemotherapy for their cancer outside of this clinical trial. If the patient is a woman, and are able to have children, they will need to have a negative pregnancy test. Patients will also have about 6 tablespoons of blood drawn for research tests before they start the study.

Early in the morning of the patient's treatment they will be admitted to the Center for Translational Science Activities (CTSA) in the Charlton Building of the Mayo Clinic complex. Fifteen to 30 minutes prior to treatment, patients will be given oral medication used to prevent or relieve pain and fever. As the treatment is human frozen plasma, these pre-medications are standard care for administration of human blood products and should
be used before treatment.

Under sterile conditions, patients will be treated with B7-DC-XAb by IV (through a needle placed in a vein in their arm). The patient will be observed for side effects in the treatment suite for 30-60 minutes before they leave the treatment area.

When done getting the study treatment
One hour after the patient is done receiving the study treatment they will have their vital signs checked, and then again at six hours after treatment. Then the patient will be dismissed, and their doctor will see the patient in followup every week for a month, at two months, and then every two months until their disease gets worse. Patients will have blood tests at each of the visits, and their disease will be evaluated by a physical exam or a scan. If the patient's disease gets worse, the patient and their doctor will decide what further treatment the patient will receive.

Mandatory (Required) Blood and Tissue Testing:
This study also has laboratory tests that will be done to study small samples of blood and biopsy tissue. A blood sample will be done by drawing 6 tablespoons of blood from a
vein. The blood will be taken just before treatment starts. Patients are going to have a biopsy to get tissue for the doctors to study. The doctor will remove some body tissue
to do some tests. These tests will be done in order to understand how the patient's cancer responds to treatment. It is hoped that this will help investigators better understand the patient's type of cancer.

The drug used in this study is considered investigational, which means it has either not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug in this research study.

How long will the Study run?

Patients will be in the study for one treatment, but they will be seen in follow-up until their disease progresses, or gets worse, up to a maximum of five years.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 04/08/2008

IRB Review and Approval Date: 10/24/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 18 patients participate from Mayo Clinic.

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

Principal Investigator: Svetomir Markovic, 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

Last updated: 06/05/2008