Phase II clinical trial of personalized peptide vaccination for malignant brain tumor patients

Phase II clinical trial of personalized peptide vaccination for malignant brain tumor patients - Peptide vaccination for malignant brain tumor patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001875

Enrollment

Registered

2009-04-13

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 brain tumor

Interventions

(1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must be satisfactory the following conditions. 1 patients must be diagnosed as malignant brain tumor. The patients must be suffering from malignant brain tumor after the standard therapy. 2 patients must be positive for HLA-A2,A24,A26 or A3 supertype. 3 patients must have immunoglobulin g reactive to at least two of candidate peptides. 4 patients must be at a score level 0-1 of performance status. 5 patients must be expected to survive more than 3 months. 6 Patients must satisfy the followings WBC is more than 2500 per mm3 Lymphocyte is more than 900 per mm3 Hb is more than 8 g per dl Platelet is more than 80000 per mm3 Serum creatinine is less than 2 times upper limit of normal Total bilirubin is less than 2 times upper limmit of normal 7 patients must be more 16 year 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 the past history of severe allergic reactions. 3. Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4. Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

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

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

Outcome results

None listed

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