Unique ID issued by UMIN | UMIN000027867 |
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Receipt number | R000029432 |
Scientific Title | Phase 1 clinical trial of WT1 peptide vaccine therapy for pediatric cancers. |
Date of disclosure of the study information | 2017/06/26 |
Last modified on | 2023/12/27 18:52:46 |
Phase 1 clinical trial of WT1 peptide vaccine therapy for pediatric cancers.
Phase 1 clinical trial of WT1 peptide vaccine therapy for pediatric cancers.
Phase 1 clinical trial of WT1 peptide vaccine therapy for pediatric cancers.
Phase 1 clinical trial of WT1 peptide vaccine therapy for pediatric cancers.
Japan |
Pediatric refractory solid tumors or leukemia
Pediatrics |
Malignancy
NO
To assess the safety and feasibility of WT1 peptide vaccination with adjuvant OK-432.
Safety
Exploratory
Safety
Overall survival, The ratio of the patients who completed the course, WT1 specific CTL rate in peripheral blood mononuclear cells (PBMCs), Lymphocyte subsets, WT1-specific interferon-gamma production of PBMCs
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Vaccine |
Seven doses of HLA-A*24- or A*02-restricted WT1 peptide (1-3mg) emulsified with 0.5-2KE of adjuvant will be intradermally injected on bilateral axillary and inguinal areas every 2 weeks. WT1 peptide dose will be adjusted according to patient's body weight (1mg of WT1 peptide for body weight (BW) <10kg, 2mg for 10kg < BW <20kg, 3mg for BW >30kg). Injection schedule can be changed within 3 days.
1 | years-old | <= |
20 | years-old | > |
Male and Female
1. Patients with pathologically proven pediatric cancers.
2. Patients treated with operation, chemotherapy, and radiotherapy accoding to standard clinical guidelines.
3. Patients who did not received any specific immunotherapy before enrollement of this trial.
4. Patients with HLA-A*02 or A*24 and having neither allergies to OK-432 nor to penicillin.
5. Patients aged 19 years or under at the time of informed concent.
6. Karnofsky performance Status (KPS) are over 60%.
7. Estimated survival duration is over 3 months.
8. Function of major organs is maintained, with the following inclusion criteria.
A) Leukocyte count>=3,000/mm3
B) Lymphocyte count>=500/ mm3
C) Platelet count>=100,000/mm3
D) Hemoglobin concentration >=10.0g/dL
E) AST/ALT <2.5x ULN
F) Serum creatinine <= 1.5xULN
G) APTT/PT-INR <= 1.5xULN
1. Patients with severe organ dysfunction, infection under treatment, blood abonormalities or bleeding tendency.
2. Patients with leukemia or lymphoma are excluded.
15
1st name | Kazuo |
Middle name | |
Last name | Sakashita |
Nagano Children's Hospital
Department of Hematology and Oncology
399-8288
3100 Toyoshina Azumino city, Nagano
0263-73-6700
sakasita@shinshu-u.ac.jp
1st name | Sakashita |
Middle name | |
Last name | Kazuo |
Nagano Children's Hospital
Department of Hematology and Oncology
399-8288
3100 Toyoshina Azumino city, Nagano
0263-73-6700
sakasita@shinshu-u.ac.jp
Nagano Children's Hospital
Nagano Children's Hospital
Self funding
Nagano Children's Hospital
3100 Toyoshina Azumino City, Nagano Prefecture
0263-73-6700
kodomo@pref-nagano-hosp.jp
NO
2017 | Year | 06 | Month | 26 | Day |
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000027867
Unpublished
none
10
Of the 24 patients, 18 completed the scheduled vaccinations. Sixteen patients had local skin symptoms and/or fever. In 1 patient, anaphylactic symptoms emerged at the time of the final injection, but these quickly subsided after the treatment. WT1-specific immunological responses were observed in 4 patients (22.2%). WT1 and HLA class I expression were confirmed in 100% and 85% of primary tumors, respectively. WT1 peptide vaccine therapy combined with OK-432 appears to be relatively safe for children.
2023 | Year | 06 | Month | 28 | Day |
Patients with pediatric cancers (Aged from 1 to 19 years)
1. Patients with severe organ dysfunction, infection under treatment, blood abnormalities or bleeding tendency.
2. Patients with leukemia or lymphoma are excluded.
Paediatric patients with a solid tumor were vaccinated with a WT1 peptide and OK-432 once every 2 weeks, for a total of seven times.
Sixteen patients had local skin symptoms and/or fever. In 1 patient, anaphylactic symptoms emerged at the time of the final injection, but these quickly subsided after the treatment.
Primary outcome: Safety
Secondary outcome: Overall survival, The ratio of the patients who completed the course, WT1-specific CTL rate in peripheral blood mononuclear cells, Lymphocyte subsets, WT1-specific interferon-gamma production of PBMCs
Completed
2017 | Year | 01 | Month | 01 | Day |
2017 | Year | 01 | Month | 01 | Day |
2017 | Year | 06 | Month | 27 | Day |
2019 | Year | 03 | Month | 30 | Day |
2017 | Year | 06 | Month | 22 | Day |
2023 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029432
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