Unique ID issued by UMIN | UMIN000006507 |
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Receipt number | R000007720 |
Scientific Title | MAGE-A4 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene" |
Date of disclosure of the study information | 2011/10/09 |
Last modified on | 2018/12/18 08:49:17 |
MAGE-A4 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene"
MAGE-A4 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene"
MAGE-A4 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene"
MAGE-A4 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene"
Japan |
Therapy-resistant esophageal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and the immune reaction in the peptide vaccinated patients who have completed "adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene"
Safety
safety
immune reaction
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Vaccine |
subcutaneous injection of MAGE-A4 peptide, 300microgram mixed with Montanide ISA-51 VG
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.Patient who completed "adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene(UMIN000002395)"
2.adverse events whith grade 1 or 2 during the above study
3.Performance status(ECOG) 0 to 1
4.Having written informed consent
1.Having following serious complications
# Uncontrolled anigina pectoris, myocardial infarction, or heart failure
# Uncontrolled diabetes mellitus or hytertention
# Uncontrolled infection
# X-ray-proven interstitial pneumonia or pulmonary fibrosis
# Autoimmune disease
# Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL
Thrombosis tendency
2.History of serious hypersensitivity
3.Unctrolled pleural effusion, ascites, or pericardial effusion
4.Uncontrolled CNS metastasis
5.Systemic corticostoroid or immuno-suppressive therapy
6. Inappropriate for MAGE-A4 143-151 peptide administration, i.e. allergic to the peptide or adjuvant
7.Mental illness or drug dependency affecting informed consent
8.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm
9. Lasting less than four weeks from the previous enrollment to clinical trials
11.Inappropriate for study entry judged by an attending physician
18
1st name | |
Middle name | |
Last name | Shinichi Kageyama |
Mie University Graduate School of Medicine
Immuno-Gene Therapy
2-174, Edobashi, Tsu, Mie 514-8507 Japan
059-231-5187
kageyama@clin.medic.mie-u.ac.jp
1st name | |
Middle name | |
Last name | Shinichi Kageyama |
Mie University Graduate School of Medicine
Immuno-Gene Therapy
2-174, Edobashi, Tsu, Mie 514-8507 Japan
059-231-5187
kageyama@clin.medic.mie-u.ac.jp
Mie University Graduate School of Medicine
Mie University
Self funding
NO
2011 | Year | 10 | Month | 09 | Day |
Published
http://clincancerres.aacrjournals.org/content/21/10/2268.long
Completed
2009 | Year | 07 | Month | 10 | Day |
2009 | Year | 09 | Month | 01 | Day |
2011 | Year | 10 | Month | 09 | Day |
2018 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007720
Research Plan | |
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Research case data | |
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