Unique ID issued by UMIN | UMIN000010929 |
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Receipt number | R000012777 |
Scientific Title | Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors |
Date of disclosure of the study information | 2013/06/11 |
Last modified on | 2019/06/17 10:28:05 |
Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Japan |
Malignant tumor
Medicine in general | Hematology and clinical oncology | Pediatrics |
Neurosurgery |
Malignancy
YES
Evaluation of safety and antitumor effects on long-term administration of WT1 peptide vaccination
Safety,Efficacy
Safety
Evaluation by NCI-CTCAE ver 4.0
1. Efficacy
2. Immune responses to WT1
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine |
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.
1 | years-old | <= |
85 | years-old | >= |
Male and Female
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
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
29
1st name | |
Middle name | |
Last name | Haruo Sugiyama |
Osaka University Graduate School of Medicine
Department of Cancer Immunology
1-7, Yamada-oka, Suita City, Osaka , Japan
06-6879-2593
sugiyama@sahs.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yusuke Oji |
Osaka University Graduate School of Medicine
Department of Clinical Laboratory Science
1-7, Yamada-oka, Suita City, Osaka , Japan
06-6879-2597
oji@sahs.med.osaka-u.ac.jp
Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Donation for department of cancer immunotherapy in Osaka Graduate School of Medicine
Self funding
NO
大阪大学医学部付属病院
2013 | Year | 06 | Month | 11 | Day |
Unpublished
Terminated
2013 | Year | 06 | Month | 03 | Day |
2013 | Year | 06 | Month | 03 | Day |
2013 | Year | 06 | Month | 03 | Day |
2019 | Year | 03 | Month | 31 | Day |
2013 | Year | 06 | Month | 11 | Day |
2019 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012777
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