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

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Melanoma, Skin Cancer

In brief

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.

Key facts

Study ID

NCT01369888

Run by

National Cancer Institute (NCI)

People needed

3

Starts

2011-05-01

Expected to finish

2014-05-01

Last updated by the study team

2015-01-27

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
• Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
• Concurrent systemic steroid therapy.
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45%.
• In patients > 60 years old, documented LVEF of less than or equal to 45%.
• Documented LVEF of less than or equal to 45% tested in patients with:
• clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or.
• age greater than or equal to 60 years old.
• Documented forced expiratory volume 1 (FEV1) less than or equal to 60% predicted tested in patients with:
• A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
• Symptoms of respiratory dysfunction.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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