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Immunotherapy

Information about the study | Study eligibility information | Study timeline | News release

A Phase 2 Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following A Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen In Metastatic Melanoma

Short Name: Y-TIL Cells for Metastatic Melanoma

Principal Investigator: John P Hanson, Jr., M.D.
Co-Investigator: Jonathan Treisman, M.D.

This clinical trial is for patients that have been diagnosed with metastatic melanoma, a type of skin cancer that has spread to other parts of the body. Patients who are interested in this study will be tested to determine whether they are eligible to participate in the study. If they are eligible, they will be asked to donate blood and have a procedure to remove tumor tissue. The blood sample and tumor will be processed in the Immunotherapy Lab at Aurora St. Luke’s Medical Center. During this processing, the lymphocytes (immune system cells) will be removed from the tumor and grown to a large number. These special lymphocytes, called Young Tumor-Infiltrating Lymphocytes or Y-TIL, may have the ability to recognize and kill cancer. Approximately 50 percent of tumors will provide Y-TIL cells and it takes about one month to grow them. During this time, patients undergo tests and scans to determine if they remain eligible to participate in the rest of the study. (See eligibility criteria.)

Once the Y-TIL cells have been grown in the lab, patients will be admitted to the hospital for chemotherapy. The chemotherapy drugs are Cytoxan and Fludarabine, which are given over seven days. The purpose of the chemotherapy drugs is to weaken the patient’s immune system to prepare it to receive the Y-TIL cells.

Once the chemotherapy is complete, patients will receive the Y-TIL cells through a tube placed into a vein in their neck or chest. Patients will then receive a drug that will help the Y-TIL cells to grow in their body, called Interleukin-2 (IL-2) every eight hours up to 15 doses over five days as tolerated. Another drug called Filgrastim will be given daily until the patient’s immune system recovers. Patients will be discharged from the hospital once the IL-2 is complete and the doctor determines they are well enough to go home.

Four to six weeks later, patients will undergo testing and a physical exam to determine the effects of the study on their health.

For more information

For more information on this clinical trial contact the Immunotherapy Program at 414-649-5818.