Malignant tumor
Conditions
Interventions
The patient is intradermally injected with the WT1 peptide emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed every two or four weeks.
Sponsors
Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as malignant solid tumors or acute leukemia and previously treated by WT1 vaccine. 2. Not expected to make any further efficacy by standard treatment 3. HLA-A*2402 positive (In the vaccine-protocol using helper peptide, HLA class DRB1*04:05,15:01,15:02,08:03,HLA-DPB1*09:01 or 05:01 positive) 4. Judged as having clinical effects due to previous WT1 vaccine 5. Meet the following criteria for organ functions 1)Neutrophil more than 1,000/microliter, Platelet more than 50,000/microliter, Hemoglobin more than 7g/dl 2) Serum creatinine less than 2.0 mg/dL 3) Serum bilirubin less than 2.0 mg/dL 4) Serum AST/GOT less than 4 folds of the upper normal limit 5) Arterial oxygen saturation more than 94% in room air 6. Age 0-85 7. Performance status (ECOG) 0-1 8. Informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1. There is deep-seated active infection. 2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial. 3. There is severe psychiatric disorder. 4. Responsible doctors judged the patient inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation by NCI-CTCAE ver 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy 2. Immune responses to WT1 | — |
Countries
Japan
Contacts
Public ContactYusuke Oji
Osaka University Graduate School of Medicine Department of Clinical Laboratory Science
Outcome results
None listed