Unique ID issued by UMIN | UMIN000002001 |
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Receipt number | R000002437 |
Scientific Title | Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors. |
Date of disclosure of the study information | 2009/05/24 |
Last modified on | 2020/06/01 11:13:52 |
Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Japan |
Malignant solid tumors,
Malignant lymphoma,
Multiple Myeloma, Acute leukemia
Medicine in general | Hematology and clinical oncology | Surgery in general |
Malignancy
YES
Safety
Efficacy
Exploratory
Explanatory
Phase I,II
1. Safety
Evaluation by NCI-CTCAE ver 3.0
2. Efficacy
Clinical response rate
Disease control rate
1. QOL outcomes
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 3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed 12 times at weekly intervals. The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria from 1 to 3 weeks after 12th WT1 vaccination .
16 | years-old | <= |
79 | years-old | >= |
Male and Female
1. Diagnosed as malignant solid tumors, malignant lymphoma, mutiple myeloma or acute leukemia.
2. Informed about his diagnosis
3. Not expected to make any further efficacy by standard treatment
4. WT1 expression in malignant cells
5. HLA-A*2402 positive
6. Having evaluable diaseas
7. No chemotherapy/radiation has been performed within 4 weeks and no hormone/BRM therapy has been performed within 3 weeks before the start of vaccination.
8. There is not uncontrolable brain metastasis.
9. Performance status (ECOG) 0-1
10. Meet the following criteria for organ functions
1)Neutrophil more than 1,000/microliter, Platelet more than 75,000/microliter, Hemoglobin more than 8g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 1.5 folds of the upper normal limit
4) Serum AST/GOT less than 3 folds of the upper normal limit
5) Serum Albumin more than 2.5g/dl
6) Arterial oxygen saturation more than 94% in room air
11. Pleural effusion, ascites and pericardial effusion are not detected or
controlled.
12 Survival period is expected more than 3 months
13. Informed consent has been obtained
1. There is deep-seated active infection.
2,3 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.
4. Dependent on total parenteral nutrition(TPN)
5. There is expanded liver metastasis.
6. There are other malignancies.
7. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD).
8. Post allogeneic hematopoietic stem cell transplantation
9. Pregnant or lactating woman
10. There is severe psychiatric disorder.
11. Responsible doctors judged the patient inappropriate for the trial
30
1st name | Haruo |
Middle name | |
Last name | Sugiyama |
Osaka University Graduate School of Medicine
Department of Clinical Laboratory Science
565-0871
1-7, Yamada-oka, Suita City, Osaka , Japan
06-6879-2593
sugiyama@sahs.med.osaka-u.ac.jp
1st name | Oka |
Middle name | |
Last name | Yoshihiro |
Osaka University Graduate School of Medicine
Department of Cancer Immunotherapy
565-9871
2-2, Yamada-oka, Suita City, Osaka, Japan
06-6879-3676
http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/index.htm
yoshi@cit.med.osaka-u.ac.jp
Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
Japan
Academic Clinical Research Center of Osaka University Hospital
2-2 yamada-0ka, Suita Cit, Osaka
0662108290
acr-jim@dmi.med.osaka-u.ac.jp
NO
2009 | Year | 05 | Month | 24 | Day |
Unpublished
No longer recruiting
2003 | Year | 10 | Month | 10 | Day |
2003 | Year | 11 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2009 | Year | 05 | Month | 24 | Day |
2020 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002437
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