Unique ID issued by UMIN | UMIN000008940 |
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Receipt number | R000010475 |
Scientific Title | Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies . |
Date of disclosure of the study information | 2012/09/19 |
Last modified on | 2014/07/14 17:06:10 |
Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies .
Phase II study of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients.
Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies .
Phase II study of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients.
Japan |
lung cancer
Pneumology |
Malignancy
NO
The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Comparison of immune-enhancing effects between two groups.
1. Comparison of safety between two groups. 2. Comparison of overall survival between two groups .
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine | Vaccine |
arm1:
The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle).
Ninjin-yoei-to (3 g/time, 3 times/day) will be orally administered from the date of the first vaccination to the date of the sixth vaccination.
The peptide vaccination will be allowed to continue till four periods (24 times ) at the interval in every 2~4 weeks.
arm2:
The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle).
The peptide vaccination will be allowed to continue till four periods (24 times ) at the interval in every 2~4 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as lung cancer resistant to standard therapies. (Patients with inoperable cancer fail the chemotherapy of three or more regimens . Patients with cancer of recurrence after resection or radiotherapy.)
2) Patients must be at a score level 0-1 of ECOG performance status.
3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types.
4)Patients must be expected to survive more than 3 months.
5) Patient's laboratory data must satisfy the followings:
WBC is more than 2,500/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dl
Platelet is more than 80,000/mm3
Serum Creatinine is less than 2 times the ULN
Total bilirubin are less than 2 times the ULN
6) Patients must be more 20 and less than 75 year-old
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
The following patients must be excluded:
1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al).
2)Active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3)Patients with the past history of severe allergic reactions.
4)patients with pulmonary disorder (idiopathic pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonia,drug-induced pneumonia).
5)(Females) Pregnant or nursing patients. Patients desiring future fertility.
(Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
6)Patients who are judged inappropriate for entry to this clinical trial by doctors.
7)Patients who has taken Ninjin-yoei-to.
80
1st name | |
Middle name | |
Last name | Kyogo Itoh |
Kurume University
Cancer Vaccine Center
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
0942-27-5210
kyogo@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
0942-31-7744
akiymd@med.kurume-u.ac.jp
Kurume University Cancer Vaccine Center
None
Other
NO
2012 | Year | 09 | Month | 19 | Day |
Unpublished
Terminated
2012 | Year | 08 | Month | 23 | Day |
2012 | Year | 09 | Month | 19 | Day |
2012 | Year | 09 | Month | 19 | Day |
2014 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010475
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