At a glance
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A Phase I/II Study of IL-15 Administration Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen and Autologous Lymphocyte Transfer in Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine, and 2 other interventions for Metastatic Melanoma and Skin Cancer. Terminated early, enrolled 3 participants across 1 site.
Signals
Detailed Summary
Background: \- 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. Objectives: -To test the effectiveness of lymphocytes drawn from tumor cells combined with interleukin-15 in treating metastatic melanoma. Eligibility: * 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.
Study Details
Timeline
Interventions
60 mg/m\^2, intravenous (IV) (in the vein) x 2 days
25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
IV over 30 minutes on day 0
IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients.