Phase II clinical trial of personalized peptide vaccination for standard therapy failure patients with malignant glioma (glioblastoma)

UMIN ID: UMIN000001243

Registered date:11/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: malignant glioma (glioblastoma)
• Date of first enrollment: 2009/04/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): <1st treatment: total 8 times, every week> Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulsion of the peptides is subcutaneously injected (3.0 mg/1.5 mL). Simultaneous BSC treatments are accepted. Day 8,15,22,29,36,43,50: Inject subcutaneously the same peptides as those of the 1st injection. Day 50-64: Final evaluation. <2nd treatment: total 8 times, every 2 weeks> The 2nd treatment would be continued according to the patient's request. The peptides are bi-weekly injected. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be modified.

Outcome(s)

• Primary Outcome: Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study.
• Secondary Outcome: 1. Progression free survival of peptide vaccination with BSC will be compared with that of BSC group. 2. Six month survival rate of the 2 groups will be compared. 3. Anti-tumor effect (clinical responses) will be evaluated by RECIST criteria. 4. Adverse effects/safety will be evaluated by CTCAE v.3.0. 5. Evaluation of immunological effects (cytotoxic T lymphocytes (CTL), anti-peptide IgG) before and after peptide vaccination.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with multiple cancers 3) Patients with the past history of severe allergic reactions. 4) Patients who are not accept contraception during the 1st vaccination to 70 days after the last vaccination. 5) Patients with positive for hepatitis B or C virus. 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,The Ministry of Health, Labor and Welfare, Japan