Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Who Can Grow and Expand T-Cells
Feasibility is the primary endpoint of this trial, which is defined as a patient who can grow and expand T-cells. We anticipate that this is feasible for at least 50% of the eligible patients. If it is feasible for seven/six or more patients out of 16 eligible patients, then we will consider to reject a feasibility rate of no more than 25%/20% in favor of at least 50% for a one-sided type I error of 0.08/0.082 and type II error of 0.227/0.105.
Average of 10 Months
Amod Sarnaik, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
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