Malignant bone and soft tissue tumors
Conditions
Interventions
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.
Sponsors
Department of Orthopaedic Surgery, Kochi Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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) Written informed consents are obtained from patients after giving sufficient explanations and obtaining their understandings about disease conditions.
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrollable infectious diseases (including active Tuberculosis). 2) Patients with severe complications(malignant hypertension, severe congestive heart failure, severe colonary insufficiency, myocardial, infarction within three months, terminal stage of liver cirrhosis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonitis, etc.). 3) Patients after allogeneic bone marrow transplantation. 4) Pregnant or breast-feeding women. 5) Patients with severe psychiatric diseases. 6) Patients who have participate in any other clinical trial. 7) Patients who have previously participated in this clinical trial. 8) Any patients disqualified by a study physician because of medical, psychological, or any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of side effects(Phase I) Progression-free survival(Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, survival rate, local control rate, overall survival, adverse events, immunological responses | — |
Countries
Japan
Contacts
Public ContactKeiko Udaka
Kochi Medical School Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Outcome results
None listed