Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma
- Researchers have developed an experimental cancer treatment called cell therapy. White blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab, and then given back to the patient. Interleukin-15, given to the patient after the cells (now called Young tumor-infiltrating lymphocytes of Young TIL cells) are replaced, helps the cells to grow and boosts the immune system. This process changes your normal cells into cells that are able to recognize your tumor has been studied in the lab. These cells can destroy tumor cells in the test tube, but scientists want to see if they work inside the body.
-To test the effectiveness of lymphocytes drawn from tumor cells combined with interleukin-15 in treating metastatic melanoma.
- Patients must be 18 - 66 years of age and have a diagnosis of metastatic melanoma.
- They will have heart and lung function tests, lab tests, and imaging procedures.
- Patients may not have conditions such as active systemic infections, blood clotting disorders, or other active major medical illnesses.
- Patients may not be pregnant or nursing.
Biological: Tumor Infiltrating Lymphocytes
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of IL-15 Administration Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen and Autologous Lymphocyte Transfer in Metastatic Melanoma|
- To determine the safety/toxicity/MTD of intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Determination of the level of reconstitution of T reg cells in patients who receive cell transfer followed by IL-15 and to determine the PK of IL-15 levels in the serum following intravenous administration. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369888
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|