Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients

Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients - Pan-HLA type personalized peptide vaccine trial for pediatric malignant glioma patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000760

Enrollment

Registered

2007-07-03

Start date

2007-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced pediatric malignant glioma patients who are refractory to standard therapies

Interventions

Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be clinically diagnosed as malignant glioma, and are refractory to standard therapies such as radiotherapy or radiochemotherapy. 2) Patients must be more 3 year-old and less 16 year-old. 3) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A31, or -A33. 4) Patients must have significant level of plasma IgG reactive to at least one of the vaccine candidate peptides. 5) The vaccine therapy must be started more than 4 weeks after the last chemotherapy. 6) Patients must be expected to survive more than 3 months. 7) Patients must satisfy the followings: WBC more than 3,000/mm3 Lymphocytes more than 1,000/mm3 Hb more than 10.0g/dl Platelet more than 100,000/mm3 Serum Creatinine less than 1.5 times of the standard value Total Bilirubin less than 1.5 times of the standard value ALT less than 2.5 times of the standard value AST less than 2.5 times of the standard value 9) Written informed consent must be obtained from patients and legally acceptable representatives. 10) Patients must be negative for Hepatitis virus B/C.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version).	—

Secondary

Measure	Time frame
Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division

akiynd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026