Metastatic melanoma
Conditions
Interventions
Tumor resection(day-28) Non-myeloablative lymphocyte depleting preparative regimen(day-7~-3) Transfer cultured tumor infiltrating lymphocytes(day0) Low-dose interleukin-2(day0~4)
Sponsors
Keio University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed metastatic melanoma. 2) Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation. 3) Greater than or equal to 20 years of age and younger than or equal to 65 years of age. 4) Life expectancy of greater than three months. 5) Clinical performance status of ECOG 0 or 1. 6) Normal values for basic laboratory values 7) More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less. 8) Able to understand and sign the Informed Consent Document. 9) Gain the cooperation of at least two family and/or friends on peripheral blood mononuclear cells apheresis.
Exclusion criteria
Exclusion criteria: 1) Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 2) Men who plan to impregnate a woman 3) Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system. 4) Patients who have active other primary malignancies 5) Patients who have severe psychiatric disease 6) History of severe immediate hypersensitivity reaction to any of the agents used in this study. 7) History of coronary revascularization or ischemic symptoms. 8) Carrier of HBV, HCV, HTLV-1, HIV and so on. 9)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
Japan
Contacts
Public ContactTakeru Funakoshi
Keio University, School of Medicine Depertment of Dermatology
Outcome results
None listed