drugset / Trial / NCT01369888

Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma

NCT01369888

Phase 1/2 Terminated 3 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-05
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject N-803 Protein / enzyme biologic 0.25 ug/kg Intravenous
Subject N-803 Protein / enzyme biologic 0.5 ug/kg Intravenous
Subject N-803 Protein / enzyme biologic 1 ug/kg Intravenous
Subject N-803 Protein / enzyme biologic 2 ug/kg Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Tumor Infiltrating Lymphocytes Cell therapy Intravenous