Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma
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
Publications
- Background Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.
- Background Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, Abrams J, Sznol M, Parkinson D, Hawkins M, Paradise C, Kunkel L, Rosenberg SA. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul;17(7):2105-16. doi: 10.1200/JCO.1999.17.7.2105.
- Background Gogas HJ, Kirkwood JM, Sondak VK. Chemotherapy for metastatic melanoma: time for a change? Cancer. 2007 Feb 1;109(3):455-64. doi: 10.1002/cncr.22427.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |