This is a phase II clinical study for patients with metastatic (the cancer has spread to other parts of the body) melanoma. Patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down. Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This study will see how useful this regimen is in treating metastatic melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
i.v., 60mg/kg per day for 2 days
i.v., 25mg/m2 per day for 5 days
i.v., 1x10\^10 - 1.6x10\^11 cells
i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Clinical response to treatment
Time frame: 6 weeks after treatment
Number occurrences and severity of side effects
Time frame: Starting at first dose of study treatment up to 10 years
Number of patients with an immunity and no immunity to the study treatment
Time frame: From start of study up to 10 years
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