Unique ID issued by UMIN | UMIN000009380 |
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Receipt number | R000011025 |
Scientific Title | Adjuvant treatment of novel multiple cancer vaccine restricted with HLA-A24 for patients with completely resected non-small cell lung cancer. randomized phase II trial |
Date of disclosure of the study information | 2012/12/01 |
Last modified on | 2015/11/21 09:17:34 |
Adjuvant treatment of novel multiple cancer vaccine restricted with HLA-A24 for patients with completely resected non-small cell lung cancer. randomized phase II trial
Adjuvant treatment of multiple cancer vaccine for patients with completely resected non-small cell lung cancer. randomized phase II trial
Adjuvant treatment of novel multiple cancer vaccine restricted with HLA-A24 for patients with completely resected non-small cell lung cancer. randomized phase II trial
Adjuvant treatment of multiple cancer vaccine for patients with completely resected non-small cell lung cancer. randomized phase II trial
Japan |
non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate the efficacy and safety of adjuvant cancer vaccine therapy in patients with completely resected stage IB-IV non-small cell lung cancer.
Safety,Efficacy
Exploratory
Phase II
Recurrence free survival
Overall survival
Antigen specific T cell responses
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Vaccine |
multiple vaccine with Montanide ISA51 VG
matched with HLA-A24
1. URLC10 (up regulated lung cancer 10,LY6K)
2. CDCA1 (cell division cycle associated 1)
3. VEGFR1
4. VEGFR2
multiple vaccine with Montanide ISA51 VG
miss-matched with HLA-A24
1. URLC10 (up regulated lung cancer 10,LY6K)
2. CDCA1 (cell division cycle associated 1)
3. VEGFR1
4. VEGFR2
20 | years-old | <= |
Not applicable |
Male and Female
1)Pathologically confirmed stage IB-IV NSCLC
2)Completely resected NSCLC by lobectomy or more with lymph node dissection
3)Age of 20 years or older
4)ECOG performance status 0-1
5)With adequate major organ functions
as defined below:
*White blood cell count 1,500-15000/mm3
*Platelet count >= 75,000/mm3
*AST <= 3 times institutional normal range
*ALT <= 3 times institutional normal range
*Creatinine <= 2 times institutional normal range
6) Be able to start within 4 week after surgery in patients without adjuvant chemotherapy treatment and within 6 week after adjuvant chemotherapy
7)Written informed consent
1. With uncontrollable ischemic heart disease and/or arhythmia
2. With acute myocardial infarction 6 months before treatment
3. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
4. With double cancer, multiple cancer
5. With active inflammatory disease
6. With steroidal or immunosuppressive agent dependency
7. Physician concludes that the patient's participation in this trial is inappropriate
60
1st name | |
Middle name | |
Last name | SUZUKI Hiroyuki |
Fukushima Medical University
Chest Surgery
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
024-547-1253
hiro@fmu.ac.jp
1st name | |
Middle name | |
Last name | SUZUKI Hiroyuki |
Fukushima Medical University
Chest Surgery
Hikarigaoka 1 Fukushima, JAPAN
024-547-1111
hiro@fmu.ac.jp
Fukushima Medical University
Regenerative Surgery, Fukushima Medical University
Self funding
NO
福島県立医科大学附属病院
2012 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2009 | Year | 01 | Month | 01 | Day |
2009 | Year | 01 | Month | 01 | Day |
2012 | Year | 11 | Month | 21 | Day |
2015 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011025
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