Unique ID issued by UMIN | UMIN000012774 |
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Receipt number | R000014397 |
Scientific Title | A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma. |
Date of disclosure of the study information | 2014/01/08 |
Last modified on | 2023/07/17 08:17:13 |
A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.
Peptides cocktail vaccine for patients with progressive or recurrent malignant glioma.
A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.
Peptides cocktail vaccine for patients with progressive or recurrent malignant glioma.
Japan |
Malignant glioma
Neurosurgery |
Malignancy
NO
A phase I/II study to evaluate the safety and clinical efficacy of cancer vaccine using URLC10 (up-regulated lung cancer 10), DEPDC1 (DEP domain containing 1), FOXM1 (forkhead box M1), KIF20A (kinesin family member 20A), VEGFR1 (Vascular Endothelial Growth Factor Receptor 1), and VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) peptides restricted to HLA-A*2402 in patients with progressive or recurrent malignant glioma.
Safety,Efficacy
Exploratory
Explanatory
Phase I,II
1) Safety
2) Clinical efficacy
Overall survival
1) Immunological responses
Induction of in vitro cytotoxic T
lymphocytes
T lymphocytes analyzed by HLA Tetramer
2) Clinical efficacy
Progression-free survival
Antitumor effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
Subcutaneous injections of URLC10, DEPDC1, FOXM1, KIF20A, VEGFR1 and VEGFR2 peptides (1mg, respectively) with IFA. Weekly administration, total 8 times.
16 | years-old | <= |
79 | years-old | >= |
Male and Female
1) malignant glioma.
2) HLA-A*2402.
3) Age between 16 to 79.
4) Performance status (ECOG) of 0-2.
5) After the postoperative treatment with temozolomide and irradiation.
6) Over 4 weeks after chemotherapy and/or irradiation
7) Sufficient function of important organs.
8) No uncontrollable pleural, peritoneal or cardiac effusion.
9) Expected survival time: more than 3 months.
10) Written informed consents are obtained.
1) Uncontrollable severe infectious diseases.
2) Serious concomitant diseases
3) Adverse event of NCI-CTC grade 3 or 4.
4) Unable to take anything orally over 24 hours.
5) Active multiple cancers.
6) Myeloproliferative diseases such as MDS and CML.
7) After allogeneic hematopoietic stem cell transplantation.
8) Active autoimmune diseases.
9) Severe drug allergy
10) Necessity for administration of steroid or immunosuppressive drugs.
11) Pregnancy or lactation. Patients hope pregnancy
12) Psychiatric disorders.
13) Unhealed injury.
14) Judged as inappropriate for this study by doctors.
20
1st name | |
Middle name | |
Last name | Masahiro Toda |
Keio University School of Medicine
Department of Neurosurgery
35 Shinanomachi, Shinjuku-ku,
03-5363-3808
todam@keio.jp
1st name | |
Middle name | |
Last name | Masahiro Toda |
Keio University School of Medicine
Department of Neurosurgery
35 Shinanomachi, Shinjuku-ku,
03-5363-3808
todam@keio.jp
Department of Neurosurgery, Keio University School of Medicine
None
Self funding
NO
慶應義塾大学病院(東京都)/Keio University Hospital(Tokyo)
2014 | Year | 01 | Month | 08 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 14 | Day |
2013 | Year | 11 | Month | 14 | Day |
2013 | Year | 12 | Month | 01 | Day |
2022 | Year | 03 | Month | 31 | Day |
2014 | Year | 01 | Month | 07 | Day |
2023 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014397
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