Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction -

Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction - - Personalized peptide vaccine trial for cancer patients - Effect of extended dose interval on the immun induction -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006927

Enrollment

Registered

2011-12-21

Start date

2012-01-01

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 tumor

Interventions

(1st course: total 3 doses with 21-28 day interval) Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before the 1st vaccination, and s.c. inj

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be pathologically diagnosed as cancer,however,it is not necessary to possess target lesionns response evaluation. 2) Patients must be at a score level 0 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides. 4)Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet is more than 80,000/mm3 Serum Creatinine is less than 2 times upper limit of nomal. Total Bilirubin is less than 2 times upper limit of nomal. 6) Patients must be more 20 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.

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) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 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 3 dose vaccination.	—

Secondary

Measure	Time frame
Adverse effects and safety of peptide vaccination is evaluated based on the CTCAE Version 4.0 .	—

Countries

Japan

Contacts

Public ContactAkira Yamada

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

akiymd@med.kurume-u.ac.jp0942-31-7572

Outcome results

None listed

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