Unique ID issued by UMIN | UMIN000003521 |
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Receipt number | R000004274 |
Scientific Title | Randomized Phase II clinical trial of personalized peptide vaccination for patients with advanced (stage IIIB/IV) or recurrence non-small cell lung cancer who had chemotheraphy of 1 or 2 regimen, to evaluate the progression free survial of docetaxel plus placebo versus docetaxel plus pesonalized pepitide vaccine. |
Date of disclosure of the study information | 2010/04/22 |
Last modified on | 2015/04/22 10:55:52 |
Randomized Phase II clinical trial of personalized peptide vaccination for patients with advanced (stage IIIB/IV) or recurrence non-small cell lung cancer who had chemotheraphy of 1 or 2 regimen, to evaluate the progression free survial of docetaxel plus placebo versus docetaxel plus pesonalized pepitide vaccine.
Randomized Phase II study of peptide vaccination in non-small cell lung cance patients.
Randomized Phase II clinical trial of personalized peptide vaccination for patients with advanced (stage IIIB/IV) or recurrence non-small cell lung cancer who had chemotheraphy of 1 or 2 regimen, to evaluate the progression free survial of docetaxel plus placebo versus docetaxel plus pesonalized pepitide vaccine.
Randomized Phase II study of peptide vaccination in non-small cell lung cance patients.
Japan |
non-small cell lung cancer
Pneumology |
Malignancy
NO
Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to non-small cell lung cancer patients. The aim of the study is to investigate the safety, immunological responses and antitumor activity.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Evaluation of antitumor activity (progression free survival) of peptide vaccination.
1.Evaluation of response rate and long-term prognosis (overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0).
3.Evaluation of immunological responses (anti-peptide IgG) before
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine | Vaccine |
Arm 1: personalized peptide vaccine plus docetaxel
(1st treatment: total 8 times, every 1 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, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: First evaluation.
(2nd treatment: total 8 times, every 2 weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides.
Day 15, 29, 43, 57, 71, 85, 99 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 99: Second evaluation.
Arm 2: placebo plus docetaxel
(1st treatment: total 8 times, every 1 weeks)
Day 1: administer placebo.
Day 8, 15, 22, 29, 36, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: First evaluation.
(2nd treatment: total 8 times, every 2 weeks)
Day 1: administer placebo.
Day 15, 29, 43, 57, 71, 85, 99 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 99: Second evaluation.
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must be satisfactory the following conditions.
1) patients had chemotheraphy of 1 or 2 regimen.
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 candidate peptides belongs to an apropriate group(s) for patient's HLA types.
4) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
5) Patients must satisfy the followings.
WBC is less than 12000 per mm3
Lymphocyte is more than 1000 per mm3
Hb is more than 8.0 g per dL
Platelet is more than 100,000 per mm3
Serum creatinine is less than 1.5 mg/dl
Total bilirubin is less than 1.5 mg/dl
6) patients must be more than 20 years old.
7) Patients must be expected to survive more than 3 months.
8) Written informed consent must be obtained from patients.
9) Prior treatment are allowed and mustcomplete 4 weeks before random assignment with full recovery of related toxicity.
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 who are during pregnancy, lactation expectant, and desiring future fertility.
4) Patients who are judged inappropriate for the clinical trial by doctors.
64
1st name | |
Middle name | |
Last name | Yoichi Nakanishi |
Kyusyu University
Research Institute for Desease of the Chest
Maidashi 3-1-1, Higashiku, Fukuoka ,Fukuoka 812-8582, Japan
1st name | |
Middle name | |
Last name | Akira Yamada |
Kurume University
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
0942-31-7572
akiymd@med.kurume-u.ac.jp
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Japan
Hirosaki University, Sendai public welfare hospital, Kyusyu University
Kurume University
NO
弘前大学(青森県)、仙台厚生病院(宮城県)、九州大学(福岡県)
Hirosaki University hospital, Sendai public welfare hospital, Kyusyu University hospital
2010 | Year | 04 | Month | 22 | Day |
Unpublished
Completed
2010 | Year | 03 | Month | 19 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 22 | Day |
2015 | Year | 04 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004274
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