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

UMIN ID: UMIN000000760

Registered date:03/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced pediatric malignant glioma patients who are refractory to standard therapies
• Date of first enrollment: 2007/06/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides. Each emulsified peptide (1 or 2 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Brain CT/MRI, and blood samples for hematology and biochemistry are taken at beginning and 1-week after the 6th vaccination.

Outcome(s)

• Primary Outcome: Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version).
• Secondary Outcome: Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination.

Key inclusion & exclusion criteria

• Age minimum: 3years-old
• Age maximum: 20years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Immunology, Kurume University School of Medicine
• Source(s) of Monetary Support: The Ministry of Education, Culture, Sports, Science, and Technology, Japan