Unique ID issued by UMIN | UMIN000001855 |
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Receipt number | R000002228 |
Scientific Title | Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic renal cell carcinoma failed to standard treatment |
Date of disclosure of the study information | 2009/04/10 |
Last modified on | 2019/12/06 15:49:27 |
Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic renal cell carcinoma failed to standard treatment
Peptide vaccination for patients with advanced/metastatic renal cell carcinoma
Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic renal cell carcinoma failed to standard treatment
Peptide vaccination for patients with advanced/metastatic renal cell carcinoma
Japan |
Renal cell carcinoma
Urology |
Malignancy
NO
Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to standard therapy failed renal cell carcinoma patients. The aim of the study is to investigate immunological responses.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
1. Evaluation of long-term prognosis (progression free survival and total survival).
2. Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
(1st treatment: total 6 times, every weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 45: Final evaluation.
The 1st treatment (total 6 times, every weeks) is finished.
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as renal cell carcinoma pathologically at the initial treatment. The patients must be suffering from advanced/metastatic renal cell carcinoma after standard treatment.
2) Patients must be at a score level of 0-1 of performance status (PS)(EOCG)
3) Patients must have IgG reactive to at least two of candidate peptides.
4) Patients must be expected to survive more than 3 months.
5) Patients must satisfy the followings:
WBC > 2,500/mm3
Lymphocyte > 1,000/mm3
Hb > 8.0g/dl
Platelet > 80,000/mm3
Serum Creatinine < 2.5 x upper limit of normal
Total Bilirubin < 2 x upper limit of normal
6) Patients must be more than 20 year-old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2, HLA-A24, HLA-A26, or HLA-A3 super type.
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4) Patients who are judged inappropriate for the clinical trial by doctors.
100
1st name | |
Middle name | |
Last name | Masanori Noguchi |
Kurume University
Research Center for Innovative Cancer Therapy, Division of Clinical Research
Asahi-machi 67, Kurume,
0942-31-7989
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Asahi-machi 67, Kurume,
0942-31-7744
akiymd@med.kurume-u.ac.jp
Kurume University School of medicine, Department of Immunology
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Japan
Kurume University
NO
2009 | Year | 04 | Month | 10 | Day |
Unpublished
Completed
2009 | Year | 03 | Month | 30 | Day |
2009 | Year | 03 | Month | 30 | Day |
2009 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2009 | Year | 04 | Month | 06 | Day |
2019 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002228
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