A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with primary malignant glioma
- 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
Not provided
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
Name Time Method 1) Safety 2) Clinical efficacy Overall survival
- Secondary Outcome Measures
Name Time Method 1) Immunological responses Induction of in vitro cytotoxic T lymphocytes T lymphocytes analyzed by HLA Tetramer 2) Clinical efficacy Progression-free survival Antitumor effects