NCT01005745

Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this research study is to find a better way to treat melanoma. This will be a single arm exploratory trial to evaluate prospectively the feasibility of, the toxicities of, and the persistence of TIL which can survive in vivo.

Detailed description

Patients are being offered admission to this study to test the side effects of an investigational treatment prepared from special immune cells (T cells) specific for melanoma. A T-cell is a type of lymphocyte. Lymphocytes are a type of white blood cell that protect people from viral infections; help other cells fight bacterial and fungal infections; produce antibodies; fight cancers; and coordinate the activities of other cells in the immune system. These special immune cells will be taken from a sample of the patient's tumor tissue that will be surgically removed from their body and grown in the laboratory. They will then given back to the patient in their veins. These cells are called tumor infiltrating lymphocytes (TIL). We wish to study the side effects of TIL when they are given with two chemotherapy drugs to temporarily decrease the patient's own immune cells and a drug called Interleukin-2 (IL-2). The two chemotherapy drugs called fludarabine and cytoxan are used to greatly reduce the number of normal lymphocytes circulating in the patient's body, called lymphodepletion, so that there will be more "space" for the cancer fighting lymphocytes (T-cells) that will be infused in their veins. We wish to find out how often these cells can shrink or slow the growth of the patient's melanoma. We also wish to find out the effects of lymphodepletion followed by TIL and high dose IL-2 on the patient's immune system. The lymphodepletion followed by TIL and high dose IL-2 is experimental, and has not been proven to help treat melanoma. The IL-2 has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic melanoma that cannot be surgically removed. The chemotherapy drugs cytoxan and fludarabine used for lymphodepletion have been approved by the FDA, but not for the treatment of metastatic melanoma. The combination of lymphodepletion followed by TIL and high dose IL-2 is not FDA approved but the FDA is permitting its use in this study.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
PROCEDURE	Surgery	Surgery to remove a tumor for growth of TIL
DRUG	Administration of Lymphodepletion	Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
OTHER	Adoptive Cell Transfer	T-cell infusion
DRUG	High Dose IL-2	Beginning approximately 12 - 16 hours after cell infusion.

Timeline

• Start date: 2009-10-20
• Primary completion: 2014-01-31
• Completion: 2025-08-18
• First posted: 2009-11-02
• Last updated: 2025-12-19
• Results posted: 2014-06-02

Locations

1 site across 1 country: United States