Head and Neck Tumor
Conditions
Interventions
3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. 24 weekly immunizations are planned.
Sponsors
Anti-tumor Immunotherapy Research Network, Department of Immunology, Kochi Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been histologically diagnosed to have one of the following head and neck tumors. adenocarcinoma, adenoid cystic carcinoma, malignant melanoma, sarcoma 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 positive for WT1 expression by immunohistochemical staining. 4) Age 15 to 85 5) Karnofsky Index >= 60 (PS 0-2 by ECG) 6) Sufficient function of critical organs including heart, lung, liver, kidney and bone marrow needs to be maintained. 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) 7) Life expectancy should be three months or greater. 8) Patients without additional malignant diseases. 9) Written informed consents are obtained from patients after giving sufficient explanations and confirming their understandings about disease conditions.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 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
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses | — |
Primary
| Measure | Time frame |
|---|---|
| Evaluation of side effects (phase I) Progression-free survival (phase II) | — |
Countries
Japan
Contacts
Public ContactKeiko Udaka
Kochi Medical School Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Outcome results
None listed