Unique ID issued by UMIN | UMIN000023422 |
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Receipt number | R000026986 |
Scientific Title | A phase two clinical trial of the personalized peptide vaccine for standard therapy-resistant pediatric cancer patients |
Date of disclosure of the study information | 2016/08/22 |
Last modified on | 2019/12/18 12:49:52 |
A phase two clinical trial of the personalized peptide vaccine for standard therapy-resistant
pediatric cancer patients
A phase two trial of peptide vaccine for standard therapy-resistant pediatric cancer patients
A phase two clinical trial of the personalized peptide vaccine for standard therapy-resistant
pediatric cancer patients
A phase two trial of peptide vaccine for standard therapy-resistant pediatric cancer patients
Japan |
The pediatric patients who are resistant
for standard therapy.
Hematology and clinical oncology | Pediatrics | Neurosurgery |
Child |
Malignancy
NO
To testify the immune response, safety, and clinical effectiveness of personalized peptide vaccine for standard therapy-resistant pediatric cancer patients
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Assessment of immune response by measurement of peptide specific IgG before and after peptide vaccination
Safety assessment (Observation of side effects)
Clinical effectiveness(overall survival period)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine |
For the standard therapy-resistant pediatric cancer patients, selected 4 personalized peptide vaccine are administered once a week for 6-8 times.
3 | years-old | <= |
18 | years-old | > |
Male and Female
1) standard therapy resistant cancer patients
2) Patients must be at a sore level of 0-1 of performance status (PS).
3) Patients must be positive for HLA-A2, HLA-A24, or HLA-A3 super type.
4) Patients must have IgG reactive to at least two of peptide of the candidate peptides restricted to the patients HLA types.
5) Patients must satisfy the followings :
WBC >and= 2,500mm3
lymphocyte >and= 1,000/mm3
Hb >and= 8.0g/dl
platelets >and= 80,000/mm3
serum creatinine <and= 2x upper limit of normal
total bilirubin ,and= 2x upper limit of normal
6) Patients must be between 6 and 17 year-old.
7)Patients must be expected to survive more than 3 months.
8) Assent documents for 6-15 year-old patients and written informed consents for 16-17 year-old patients must be obtained. Moreover, informed consents are obtained from their caregivers.
9) Patients must be referred from pediatric cancer specialists.
The following patients must be excluded :
1) Patients with severe symptoms (active and severe infections, circulatory disease, respiratory disease, kidney disease,immunodeficiency, disturbance of coagulation).
2) Active double cancer (synchronous double cancer and meta-chronous double cancer within 3 disease-free years),excluding carcinoma in situ (lesions equal to intra-epithelial or intra-mucosal cancer) judged to have been cured with local treatment.
3) Patients with leukemia
4) Patients with the past history of severe allergic reactions.
5) Patients who hope for pregnancy
6) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
7) Patients who are judged inappropriate for entry to this trial by doctors.
50
1st name | |
Middle name | |
Last name | Keiko Oda |
Kurume University
Cancer vaccine center
#155-1,Kokubu-machi,Kurume-city, Fukuoka, japan, 839-0863
0942-27-5210
oda_keiko@med-kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Keiko Oda |
Kurume University
Cancer vaccine center
#155-1,Kokubu-machi, Kurume-city,Fukuoka, Japan, 839-0863
0942-27-5210
oda_keiko@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
none
Self funding
NO
久留米大学がんワクチンセンター(福岡県) Kurume University Cancer Vaccine Center
(Fukuoka)
2016 | Year | 08 | Month | 22 | Day |
Unpublished
Completed
2016 | Year | 07 | Month | 22 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 08 | Month | 22 | Day |
2020 | Year | 01 | Month | 31 | Day |
2016 | Year | 08 | Month | 01 | Day |
2019 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026986
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