Unique ID issued by UMIN | UMIN000002282 |
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Receipt number | R000002793 |
Scientific Title | Phase II clinical trial of personalized peptide vaccination for patients with sarcoma. |
Date of disclosure of the study information | 2009/08/03 |
Last modified on | 2019/10/30 13:18:14 |
Phase II clinical trial of personalized peptide vaccination for patients with sarcoma.
Peptide vaccination fo patients with sarcoma.
Phase II clinical trial of personalized peptide vaccination for patients with sarcoma.
Peptide vaccination fo patients with sarcoma.
Japan |
sarcoma
Hematology and clinical oncology | Orthopedics |
Malignancy
NO
Up to 4 from the 31 candidate peptides, to which peptide specific immunoglobulin g are detected before vaccination,are administered to standard therapy failed
sarcoma patients. The aim of the study is to investigate immunological response.
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 with 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 | Vaccine |
(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
18 | years-old | <= |
Not applicable |
Male and Female
The subjects must be satisfactory the following conditions.
1 patients must be diagnosed as sarcoma.
2 patients must be positive for HLA-A2,A24,A26 or A3 supertype.
3 patients must have immunoglobulin g reactive to at least two of candidate peptides.
4 patients must be at a score level 0-1 of performance status.
5 patients must be expected to survive more than 3 months.
6 Patients must satisfy the followings
WBC is more than 2500 per mm3
Lymphocyte is more than 900 per mm3
Hb is more than 8 g per dl
Platelet is more than 80000 per mm3
Serum creatinine is less than 2 times
upper limit of normal
Total bilirubin is less than 2 times upper limmit of normal
7 patients must be more 18year old.
8 written informed consent must be obtained from patients.
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 | kyougo Itoh |
Kurume University
Cancer Vaccine Center
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
0942-27-5210
yutani@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Akira YAMADA |
Kurume University
Research center of Innovative Cancer Therapy
Asahimachi 67, kurume, fukuoka 830-0011
0942-31-7744
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
None
Other
NO
2009 | Year | 08 | Month | 03 | Day |
Unpublished
Completed
2009 | Year | 07 | Month | 15 | Day |
2009 | Year | 07 | Month | 15 | Day |
2009 | Year | 08 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2009 | Year | 08 | Month | 02 | Day |
2019 | Year | 10 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002793
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