NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedRecurrent, Progressive and Refractory Brain Tumors
Date of first enrollment07/02/2018
Target sample size20
Countries of recruitment
Study typeInterventional
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 OutcomeSafety and clinical efficacy of Vaccine therapy using VEGFR1 and VEGFR2 peptide for recurrent, progressive and refractory brain tumors
Secondary Outcome1 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
Age maximum<= 79age old
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Yukina Morimoto
Address 35 Shinano-machi, Shinjuku-ku, Tokyo Tokyo Japan 1608582
Telephone +81-353633808
E-mail hichoricco@keio.jp
Affiliation Keio university
Scientific contact
Name Masahiro Toda
Address 35 Shinano-machi, Shinjuku-ku, Tokyo Tokyo Japan 1608582
Telephone +81-353633808
E-mail todam@keio.jp
Affiliation Keio university