Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients
Phase 1
- Conditions
- Advanced pediatric malignant glioma patients who are refractory to standard therapies
- Registration Number
- JPRN-UMIN000000760
- Lead Sponsor
- Department of Immunology, Kurume University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
The following patients must be excluded: 1) Patients with cerebral or cerebellar grade I or II glioma. 2) Patients with severe symptoms (circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc). 3) Patients with the past history of severe allergic reactions. 4) Patients with active infectious disease 5) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 6) Patients who are judged inappropriate for the clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version).
- Secondary Outcome Measures
Name Time Method Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination.