IRB Number:

169-06

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to:
- Test the safety of the NY-ESO-1b/resiquimod vaccine
- See what effects (good and bad) the NY-ESO-1b/resiguimod vaccine has on a patient
- See if using the vaccine as a gel versus injection is more effective in stimulating the immune system

Both agents used in this study (NY-ESO-1b and resiquimod) have been approved by the U.S. Food and Drug Administration (FDA) for use in clinical trials. Neither has been approved for commercial use.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with stage II, III, or IV melanoma removed in the past and are being followed for relapse
-At lease four weeks since any prior chemotherapy

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

What is Involved With this Study?

The research staff is testing the safety of a new vaccine to possibly prevent relapse of this type of melanoma. We would like to administer this vaccine in different ways to determine if one way is more effective.

This study has required laboratory tests that will be done to study small samples of blood and tumor tissue. A blood sample will be done by drawing some blood from a vein. The blood will be taken just before treatment starts, weekly for four weeks and at the eight week follow-up visit. Melanoma tissue that has been removed from the patient in the past will be studied to help understand how the vaccine could affect the cancer.

The first group of participants that takes part on this study will undergo a single injection of the NY-ESO-1b vaccine under the skin along with topical application of the immune boosting agent resiquimod. The treated area of the skin will be covered with a transparent dressing (Tegaderm) that could be removed eight hours later and the skin washed with running water. The vaccine will be applied only ONCE.

The next group of participants taking part on this study will receive both the NY-ESO-1b vaccine and the immune boosting agent resiquimod as a single topical application (not injected) to an area of prepared skin. In order to allow for the vaccine to be absorbed through the skin, the top layers of the skin will be removed using tape application and stripping (Scotch clear tape will be applied and quickly removed five times prior to vaccine administration). Following skin preparation, the vaccine fluid will be applied to the area of the skin and allowed to absorb fully. Then, resiquimod gel will be applied. The treated area of the skin will be covered with a transparent dressing (Tegaderm) that could be removed eight hours later and the skin washed with running water. The vaccine will be applied only ONCE

A third group of patients will receive both the immune boosting agent, resiquimod, and the topical NY-ESO-1b. The best dose of resiquimod determined in step 1, will be applied to one of three different surface areas of the skin.

In addition to blood tests, participants in this study will undergo skin hypersensitivity testing (delayed hypersensitivity testing). This is a type of allergy test where a common allergen is injected into the skin and the skin-reaction is evaluated by a nurse 48 hours later. This test is a measure of overall immune reactivity in the patient and will be performed using three common allergens (three injections). This test is usually done on the opposite limb from the site of vaccine administration.

How long will the Study run?

Patients will be in the study for two months (single vaccine administration and follow-up blood tests), but they will be seen in follow-up for as long as their physician feels it is necessary.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 04/11/2006

IRB Review and Approval Date: 02/09/2006

Study Type: Treatment

Projected Accrual: The plan is to have up to 35 patients participate at 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: 05/07/2008