Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against malignant bone and soft tissue tumors: a phase I/II study

INTERVENTION: 3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. The administration interval is essentially every week. 24 weekly immunizations are planned. CONDITION: Malignant bone and soft tissue tumors PRIMARY OUTCOME: Evaluation of side effects(Phase I); Progression‐free survival(Phase II) SECONDARY OUTCOME: Disease control rate, survival rate, local control rate, overall survival, adverse events, immunological responses INCLUSION CRITERIA: 1) Patients who have been histologically diagnosed as either malignant bone tumor or malignant soft tissue tumor. 2) Patients must bear at lease one copy of either HLA‐A*24:02, A*02:01, A*02:06, or A*02:07 gene. 3) The tumor tissue is positibe by stained for WT1 by immunohistochemistry. 4) Age 13 to 88 5) The patients' Karnofsky Index should be 60% or more(performance status (ECOG should be 0‐2). 6) Expected survival time should be three months or greater. 7) Sufficient function of important organs including heart, lung, liver, kidney and bome marrow. And patients must satisfy the followings: Creatinin <= 3.0mg/dl BUN <= 25 mg/dl Total Bilirubin <= 1.5 mg/dl AST <= 105 U/l ALT <= 120 U/l Neutrophil >= 1,500/mm3 Platelet >= 75,000/mm3 Hemoglobin >= 8.0g/dl ECG: no serious irregularities PaO2 >= 70mmHg (room air) 8) Patients without additional malignant diseases 9) Writ