Malignant solid tumors, Malignant lymphoma, Multiple Myeloma, Acute leukemia
Conditions
Interventions
The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was schedule
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, malignant lymphoma, mutiple myeloma or acute leukemia. 2. Informed about his diagnosis 3. Not expected to make any further efficacy by standard treatment 4. WT1 expression in malignant cells 5. HLA-A*2402 positive 6. Having evaluable diaseas 7. No chemotherapy/radiation has been performed within 4 weeks and no hormone/BRM therapy has been performed within 3 weeks before the start of vaccination. 8. There is not uncontrolable brain metastasis. 9. Performance status (ECOG) 0-1 10. Meet the following criteria for organ functions 1)Neutrophil more than 1,000/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 3 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 is expanded liver metastasis. 6. There are other malignancies. 7. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD). 8. Post allogeneic hematopoietic stem cell transplantation 9. Pregnant or lactating woman 10. There is severe psychiatric disorder. 11. Responsible doctors judged the patient inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety Evaluation by NCI-CTCAE ver 3.0 2. Efficacy Clinical response rate Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. QOL outcomes 2. Immune responses to WT1 | — |
Countries
Japan
Contacts
Public ContactOka Yoshihiro
Osaka University Graduate School of Medicine Department of Cancer Immunotherapy
Outcome results
None listed