IRB Number:

1189-05

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to learn about the anti-tumor effectiveness of a heat shock vaccine in patients with stage 4 metastatic malignant melanoma.

Who is Eligible to Participate in the Study?

Adult patients diagnosed with metastatic melanoma which has spread to the liver.

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

What is Involved With this Study?

There will be 3 different treatment groups for this study. Group 1: The first 3 patients will receive radiofrequency therapy (heat treatment), along with the drug GM-CSF injected into the tumor. The tumors will be found and watched by ultrasound, CT or MRI scans. Group 2: The following 3 patients enrolled on the study will receive radiofrequency therapy, followed by radiofrequency ablation, and the drug GM-CSF injected into their tumor. Radiofrequency ablation uses radiofrequency (high energy) to treat tumors. With this treatment, high-frequency currents are passed from the tip of a needle into the tissue around the tumor. This treatment will heat and destroy a large part of the tumor. The tumors will be found and watched by ultrasound, CT or MRI scans. Group 3: The last 3 patients enrolled on study will receive radiofrequency therapy, followed by cryo-therapy, along with the drug GM-CSF injected into the tumor. Cryoablation uses freezing temperatures to treat tumors. Cryoablation works by creating freezing temperatures within a probe. When this probe is inserted into a tumor, the tumor or parts of the tumor can be frozen and destroyed. The tumors will be found and watched by ultrasound, CT, or MRI scans.

How long will the Study run?

Patients will be in the hospital for 2 days for treatment and observation. There will be up to 8 follow-up visits for a one year period.

Sponsor(s): Mayo Clinic

Study Activation: 11-25-2005

IRB Review and Approval Date: 7-21-2005

Study Type: Treatment

Projected Accrual: 9 patients

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

Principal Investigator: Dr. Svetomir Markovic

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