Advanced malignant melanoma
Conditions
Interventions
Metastasectomy (day-35) Non-myeloablative lymphocyte depleting preparative regimen (day-7~-3) Transfer cultured tumor infiltrating lymphocytes (day0) Low-dose interleukin-2(72,000IU/kg, q8hr) (day
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have histopathologically confirmed malignant melanoma. 2) Have unresectable stage 3 or 4 melanoma that are resistant to existing therapy. 3) Have the presence of measurable lesion. And also have at least one resectable lesion greater than 1 cm in diameter, that only needs 1-2 weeks hospital stay for resection) 4) Be male or female subjects, greater than or equal to 20 years of age and younger than or equal to 65 years of age. 5) Life expectancy of greater than three months. 6) Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1. 7) Major organ function (bone marrow, liver, kidney etc.) ; a) Leukocyte count >=3,000/mm3 b) Number of neutrophils >=1,000/mm3 c) Number of platelets >=100,000/mm3 d) Hemoglobin >=8.0g/dL e) AST and ALT <=150IU/L f) Total bilirubin <=3.0mg/dL g) Creatinine clearance >=30mL/min/1.73m2 8) Have already stopped prior chemotherapy and recovered enough to receive the preparative regimen. 9) Agreed to use an adequate method of contraception within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. 10) Able to understand and sign the Informed Consent Document.
Exclusion criteria
Exclusion criteria: 1) Have experienced non-myeloablative lymphocyte depleting preparative regimen or myeloablative lymphocyte depleting preparative regimen. 2) Have central nervous system infiltration that causes symptoms. 3) Subjects with intraocular melanoma. 4) Women who are pregnant or breastfeeding. 5) Subjects who take immunosuppressant drugs or adrenocortical steroid*. (*Excluding subjects who had adrenal insufficiency due to anti-PD1 or anti-CTLA4 antibodies therapy, which need steroid replacement dose) 6) Have active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system. 7) Have active other multiple primary malignancies. 8) Have active autoimmune disease. 9) Have a history of severe allergy to cyclophosphamide, fludarabine and IL-2. 10) Left ventricular ejection fraction (LVEF) <=50% 11) Forced expiratory volume in 1 second (FEV1.0%)<=60% 12) Has known history of HBV, HCV, HTLV-1, HIV. 13) Be determined to be ineligible by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration response, Duration of stable disease, Progression-free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactMaki Ishii
Keio University School of Medicine Department of Dermatology
Outcome results
None listed