solid tumor, malignant lymphoma, acute leukemia
Conditions
Interventions
Administration of WT1 peptide vaccine
Sponsors
Osaka University Graduate Shool of Medicine, Functional Diagnostic Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. diagnosed as having malignant tumor and treated with WT1 peptide vaccine in the following clinical trials in Osaka University Hospital WT1 peptide vaccine for solid tumor WT1 peptide vaccine for malignant lymphoma WT1 peptide vaccine for hematologic malignancies after allogeneic stem cell transplantation phase I Dose-increasing WT1 peptide vaccine for MDS phase I 2. Clinical usefulness of WT1 peptide vaccine was observed and its usefulness was accepted by a board 3. Neutrophyl >= 1,000/ul no use of hematopoietic factors within 14days SpO2>=94 percent (room air) Plt>=50,000/ul no transfusion of platelet within 14days Hb>=8g/dl no transfusion of RBC within 14 days serm Crn <= 2.0mg/dL serum T.Bil<=2.0 mg/dl serum AST ALT <= 120U/L 4. Age: 20<=, <=85. 5.ECOG Performance Status (PS) 0-1 6. Written informed consent was obtained.
Exclusion criteria
Exclusion criteria: 1. having severe infectious disease 2. having developed adverse effects (grade >=4) in the prior WT1 peptide vaccine trial 3. having severe complications 4. having severe mental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DTH to WT1 peptide Frequency of WT1 specific CTLs | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 1 Numbers and frequencies of adverse effects defined in NCI-CTCAE v4.0 2 Frequencies of hematological- and non-hematological adverse effects which result in suspension or withdrawal of WT1 peptide vaccine Anti-tumor effects Anti-tumor effects are evaluated at 3-6 months intervals by the method described elsewhere. | — |
Countries
Japan
Contacts
Public ContactYusuke Oji
Osaka University Graduate School of Medicine Cancer Stem Cell Biology
Outcome results
None listed