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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001243

Enrollment

Registered

2008-07-11

Start date

2009-04-01

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

malignant glioma (glioblastoma)

Interventions

&lt

1st treatment: total 8 times, every week&gt

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 pept

2nd treatment: total 8 times, every 2 weeks&gt

The 2nd treatment would be continued according to the patient&#39

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1. Patients must be diagnosed as glioblastoma pathologically and failure to radiation and/or chemotherapy. 2. Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Patient with PS3 is acceptable if limited to neural symptoms. 3. Patients must be positive for HLA-A24. 4. Patients must have IgG reactive to at least two of peptide candidates. 5. Patients must be expected to survive more than 3 months. 6. Patients must satisfy the followings: WBC >3,000/mm3 Lymphocyte >900/mm3 Hb >8.0g/dL Platelet >75,000/mm3 Serum Creatinine >2.0 mg/dL Total Bilirubin >1.5 mg/dL 7. Patients must be more 20 years old. 8. Written informed consent must be obtained from patients.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Outcome results

None listed

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