Unique ID issued by UMIN | UMIN000029005 |
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Receipt number | R000033187 |
Scientific Title | VEGFR1/2 Peptide Vaccine in Patients with Recurrent, Progressive and Refractory Brain Tumors |
Date of disclosure of the study information | 2017/10/01 |
Last modified on | 2018/10/15 17:22:48 |
VEGFR1/2 Peptide Vaccine in Patients with Recurrent, Progressive and Refractory Brain Tumors
VEGFR 1/2 Peptide Vaccine for Recurrent, Progressive and Refractory Brain Tumors
VEGFR1/2 Peptide Vaccine in Patients with Recurrent, Progressive and Refractory Brain Tumors
VEGFR 1/2 Peptide Vaccine for Recurrent, Progressive and Refractory Brain Tumors
Japan |
Recurrent, Progressive and Refractory Brain Tumors(hemangiopericytoma, hemangioblastoma, WHO grade II or III meningioma, chordoma, ependymoma)
Neurosurgery |
Others
NO
A phase I/II study to evaluate the safety and clinical efficacy of vaccine using VEGFR-1/2 peptides restricted to HLA-A*2402, A*0201 in patients with recurrent, progressive and refractory brain tumors (hemangiopericytoma, hemangioblastoma, WHO grade IIor III meningioma, chordoma, ependymoma).
Efficacy
Exploratory
Explanatory
Phase I,II
Safety and clinical efficacy of Vaccine therapy using VEGFR1 and VEGFR2 peptide for recurrent, progressive and refractory brain tumors
1 Progression free survival: PFS
2 QoL (Quality of Life):EORTC QLQ-C30,EORTC BN20,MDASI-BT
3 NCF (Neurocognitive Function):MMSE,HVLT-R,TMT,COWA
4 immune reaction (Cytotoxic T lymphocyte(CTL),TCR)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
1
Treatment
Vaccine |
Subcutaneous injection of VEGFR1 and VEGFR2 peptides (2mg, respectively) with IFA. Weekly administration, 4 times and then monthly administration, 4 times; total 8 times.
12 | years-old | <= |
79 | years-old | >= |
Male and Female
1) recurrent, progressive and refractory brain tumors (hemangiopericytoma, hemangioblastoma, WHO grade II or III meningioma, chordoma, ependymoma) without surgical and radiorogical justification
2) announcement of a diagnosis
3) HLA-A*2402, A*0201, A*0206, A*0207
4) Age between 12 to 79
5) Performance status (ECOG) of 0-2
6) Over 4 weeks after surgery, irradiation, or chemotherapy.
7) Sufficient function of important organs.
8) No uncontrollable pleural, peritoneal or cardiac effusion.
9) Expected survival time: more than 3 months.
10) preventing conception
11) 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, Shinano-machi, Shinjuku-ku, Tokyo
03-5363-3808
todam@keio.jp
1st name | |
Middle name | |
Last name | Masahiro Toda |
Keio university school of medicine
Department of Neurosurgery
35, Shinano-machi, Shinjuku-ku, Tokyo
03-5363-3808
http://www.neurosurgery.med.keio.ac.jp/medic/clinical_research.html
todam@keio.jp
Keio university school of medicine
Keio university school of medicine
Other
NO
2017 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 09 | Month | 05 | Day |
2017 | Year | 10 | Month | 01 | Day |
2017 | Year | 09 | Month | 05 | Day |
2018 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033187
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