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A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with primary malignant glioma

Phase 1
Recruiting
Conditions
Malignant glioma
Registration Number
JPRN-UMIN000013381
Lead Sponsor
Department of Neurosurgery, Keio University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) Safety 2) Clinical efficacy Overall survival
Secondary Outcome Measures
NameTimeMethod
1) Immunological responses Induction of in vitro cytotoxic T lymphocytes T lymphocytes analyzed by HLA Tetramer 2) Clinical efficacy Progression-free survival Antitumor effects
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