UVA Health System, Human Immune Therapy Center, seeks adults 18 years or older with a diagnosis of subcutaneous or cutaneous Stage IIIB- IV metastatic melanoma for research study.

The purpose of the study is to determine the safety of administration of intratumoral interferon gamma with a peptide-based vaccine in study subjects with cutaneous or subcutaneous metastases of melanoma amenable to biopsy and to evaluate the immune effects of the vaccine at the tumor sites. The study involves vaccine injections in two treatment cycles, along with the one time administration of interferon gamma. There are11 study visits total, over 26 weeks, with each visit lasting 1-5 hours.

During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, 15. During cycle two, three vaccines will be administered over a 9-week period on days 24, 43, 64. On day 22, subjects will have one or more tumor sites injected with 0.5-2 million IU of interferon gamma. Biopsies (either incisional, core or excisional) of cutaneous or subcutaneous metastatic melanoma will be obtained on day 1 (baseline), day 22 (1 week after third vaccine) and day 24 (48 hours after intratumoral injection of interferon gamma). Additional biopsies on these study days and on Day 55 may be obtained in subjects with more than minimal tumor requirement. Research blood will be drawn on days 1, 22, 24, 43, 64, 90, 183.

Screening for this study requires that HLA (human leukocyte antigen) testing be performed, with a result of HLA-A1, A2, A3, or A11. 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.

Compensation

No compensation is provided for this study.