Unique ID issued by UMIN | UMIN000013251 |
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Receipt number | R000004349 |
Scientific Title | Immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy. |
Date of disclosure of the study information | 2014/02/24 |
Last modified on | 2014/02/25 10:10:35 |
Immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Immunotherapy with WT1 peptide vaccine for pediatric patients with bone or soft tissue sarcoma following conventional chemotherapy.
Japan |
Pediatric soft tissue malignancy and neuroblastoma
Child |
Malignancy
NO
To investigate the efficacy of WT1 peptide-based vaccine as the maitenance tharapy following conventional chemotherapy for the patients with pediatric soft tissue malignancy.
Efficacy
Exploratory
Phase II
2-year progress free survival rate
overall survival, safety,
4 -year progress free survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Vaccine |
The patient is intradermally injected with 0.5-3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination is scheduled to be performed 12 times at weekly intervals. The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria after 12th WT1 vaccination . If no SAE, the vaccination is continued bi-weekly or monthly.
Not applicable |
20 | years-old | > |
Male and Female
Metastatic or recurrent rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, and Neuroblastoma.
HLA A2402
WT1 pathologically positive
CTC-AE grade 1
1)
active infectious diseases
2) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
3) Other severe problems unsuitable for this study active infectious diseases
22
1st name | |
Middle name | |
Last name | Yoshiko Hashii |
Osaka University Graduate School of Medicine
Pediatrics
2-2, Yamada-oka, Suita City, Osaka , Japan
06-6849-3932
yhashii@ped.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshiko Hashii |
Osaka university graduate school of medicine
Pediatrics
2-2, Yamada-oka, Suita-city, Osaka, Japan
06-6879-3932
areken@ped.med.osaka-u.ac.jp
Osaka university graduate school of medicine
the Japanese Ministries of Education, Culture, Sports, Science and Technology
NO
2014 | Year | 02 | Month | 24 | Day |
Unpublished
Completed
2008 | Year | 08 | Month | 20 | Day |
2008 | Year | 08 | Month | 20 | Day |
2014 | Year | 02 | Month | 24 | Day |
2014 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004349
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