JRCT ID: jRCTs031180162
Registered date:27/02/2019
VEGFR 1/2 Peptide Vaccine for Recurrent, Progressive and Refractory Brain Tumors
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Recurrent, Progressive and Refractory Brain Tumors |
Date of first enrollment | 07/02/2018 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Subcutaneous injection of VEGFR1 and VEGFR2 peptides (2mg, respectively) with IFA. Weekly administration, 4 times and then monthly administration, 4 times; total 8 times. Peptides are injected 8 times every week (plus or minus 2 days), then 6 times monthly thereafter (plus or minus 7 days). |
Outcome(s)
Primary Outcome | Safety and clinical efficacy of Vaccine therapy using VEGFR1 and VEGFR2 peptide for recurrent, progressive and refractory brain tumors |
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Secondary Outcome | 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) |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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Age maximum | <= 79age old |
Gender | Both |
Include criteria | 1) recurrent, progressive and refractory brain tumors (hemangiopericytoma, hemangioblastoma, 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. |
Exclude criteria | 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. |
Related Information
Primary Sponsor | Toda Masahiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000029005 |
Contact
Public contact | |
Name | Yukina Morimoto |
Address | 35 Shinano-machi, Shinjuku-ku, Tokyo Tokyo Japan 1608582 |
Telephone | +81-353633808 |
hichoricco@keio.jp | |
Affiliation | Keio university |
Scientific contact | |
Name | Masahiro Toda |
Address | 35 Shinano-machi, Shinjuku-ku, Tokyo Tokyo Japan 1608582 |
Telephone | +81-353633808 |
todam@keio.jp | |
Affiliation | Keio university |