Recurrent malignant glioma
Conditions
Interventions
The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9--mer modified WT1 peptide (p235-243:CYTWNQMN) and 0.75mg, 1.5mg or 3mg of 16-mer WT1 helper peptide (p 332-347:KRYFKLSHL
Sponsors
Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as malignant glioma 2. Informed about his diagnosis 3. Not expected to make any further efficacy by standard treatment 4. WT1 expression in malignant cells 5. Having any one of HLA-class II type: HLA-DRB1*0405, 1501, 1502, 0803,HLA-DPB1*0901, 0501 6. Having evaluable diaseas 7. No chemotherapy/radiation has been performed within 4 weeks and no BRM therapy has been performed within 3 weeks before the start of vaccination. 8. Aged 16 and over, and 79 and under 9. Performance status (ECOG) 0-1 10. Meet the following criteria for organ functions 1) Neutrophil more than 1,500/microliter, Platelet more than 75,000/microliter, Hemoglobin more than 8g/dl 2) Serum creatinine less than 2.0 mg/dL 3) Serum bilirubin less than 1.5 folds of the upper normal limit 4) Serum AST/GOT less than 4 folds of the upper normal limit 5) Serum Albumin more than 2.5g/dl 6) Arterial oxygen saturation more than 94% in room air 11. Pleural effusion, ascites and pericardial effusion are not detected or controlled. 12. Survival period is expected more than 3 months 13. Informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1. There is deep-seated active infection. 2,3. 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. 4. Dependent on total parenteral nutrition(TPN) 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD). 7. Post allogeneic hematopoietic stem cell transplantation 8. Pregnant or lactating woman 9. There is severe psychiatric disorder. 10. Responsible doctors judged the patient inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Antitumor effect (RECIST) 2. Performance status (ECOG) 3. Progression-free survival time 4. Immune response to WT1 | — |
Countries
Japan
Contacts
Public ContactAkihiro Tsuboi
Osaka University Graduate School of Medicine Department of Cancer Immunotherapy
Outcome results
None listed