Adults over 18 with cutaneous metastatic melanoma wanted for imiquimod with or without Vaccine study.
Combination Therapy of Topical Imiquimod plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma (Mel53)
Slingluff Craig, L
UVa Health System, Human Immune Therapy Center, seeks adults 18 years or older with a diagnosis of cutaneous Stage IIIB- IV metastatic melanoma for research study. The purpose of the study is to determine the safety of an investigational peptide-based vaccine in combination with the administration of topical imiquimod cream in patients with skin metastases of melanoma. The study involves daily topical applications of the cream (which has been approved by the FDA) applied to one or more skin melanoma lesions. You will also be randomized to one of two groups to determine whether or not you will receive the investigational vaccine. Both groups will also have biopsies of skin melanoma lesions at three or more different times. There are 10 study visits total, over 12 weeks, with each visit lasting 1-5 hours. Screening for this study requires that HLA (human leukocyte antigen) testing be performed, with a result of HLA-A1, A2, A3, or A11 being a match for the study. This test determines the tissue type of your white blood cells and is like typing your blood for donating to or receiving blood from other people. Additional lab tests will be performed on your blood, including HIV and Hepatitis C testing and a pregnancy test for women of childbearing age. Scans will be done of your Chest, Abdomen, Pelvis and Head as part of the screening. No compensation is provided for this study. Contact Information: For more information please contact: " Alison Gaucher at firstname.lastname@example.org or 434-982-1901 " IRB-HSR # 15168 Principal Investigator: Dr. Craig L. Slingluff, Jr.