unresectable malignant melanoma
Conditions
Interventions
Carboplatin AUC5/day day1, paclitaxel 175mg/m2/day day1, Dendritic cell day8, 22, q4w, 3 cycle
Sponsors
Keio University, School of Medicine
Tokyo Midtown Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathologically proven unresectable malignant melanoma patients 2)Possess HLA-A02 or HLA-A24 3)Patients who don't have immediate allergy to melanoma peptide 4)Obtains lesion that can be evaluated by RECIST 5)At least 4 weeks after the prior treatment 6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 7)Adequate hematologic, hepatic, renal, and cardiac function a)WBC >=3,000/mm3 b)Absolute neutrophil count 1,500/mm3 c)Platelet >=100,000/mm3 d)Hemoglobin >=9.0g/dL e)AST and ALT <=150IU/L f)Total bilirubin <=3.0mg/dL g)Creatinine <=1.5mg/dL h)ECG normal 9)Patients who have a life expectancy of more than 4 months 10)Patients who have given informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who have active other primary malignancies 2)Patients who have past history of severe allergy 3)Patients who have severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes) 4)Patients who have pleural effusion or pericardial fluid requiring treatment 5)Patients who are pregnant or nursing 6)Male hope to impregnate 7)Carrier of HBV, HCV, HTLV-1, HIV and so on 8)Patients who have severe psychiatric disease 9)Patients who have past history of autoimmune disease 10)During treatment with immunosuppressive agents 11)During treatment with Disulfiram, Cyanamide, carmofur or Procarbazine Hydrochloride 12)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events Response rate Progression free survival Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune induction (Delayed type hypersensitivity DTH for melanoma-antigen peptide) | — |
Countries
Japan
Contacts
Public ContactTakeru Funakoshi
Keio University, School of Medicine Depertment of Dermatology
Outcome results
None listed