Phase II Clinical trial of personalized peptide vaccine for patients with maligant tumors (gastrointestinal cancers, hepato-biliary-pancreatic cancers, thoracic malignant tumors, non-epithelial malignant tumors, genitourinary cancers, gynecological cancers, breast cancers, and rare cancers) - Effect of extended interval dosing on immune responses -

Phase II Clinical trial of personalized peptide vaccine for patients with maligant tumors (gastrointestinal cancers, hepato-biliary-pancreatic cancers, thoracic malignant tumors, non-epithelial malignant tumors, genitourinary cancers, gynecological cancers, breast cancers, and rare cancers) - Effect of extended interval dosing on immune responses - - Personalized peptide vaccine trial for patients with maligant tumors - Effect of extended interval dosing on immune responses -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011230

Enrollment

800

Registered

2013-07-23

Start date

2013-07-23

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 4 doses with 21-28 day interval) Vaccine peptides (up to 4), to which peptide-specific IgGs are detected, are selected from 31 candidate peptides before the 1st vaccination and s.c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be pathologically diagnosed as cancer. Target lesions for evaluating responses are not necessary. 2) Patients must be at a score level of 0 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides in plasma before vaccination. 4)Patients must be expected to survive more than 4 months. 5) Patients must satisfy the followings: WBC count is more than 2,500/mm3. Lymphocyte count is more than 900/mm3. Hb is more than 8.0g/dl. Platelet count is more than 80,000/mm3.(50000/mm3 in hepatocellular carcinoma) Serum Creatinine is less than 2 times upper limit of nomal (or less than 2.5 times upper limit of nomal in urological cancers). Total Bilirubin is less than 2 times upper limit of nomal. 6) Patients must be more than 18 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 underlying diseases (active and severe infectious diseases, cardiovascular diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients who are pregnant, nursing, or want to be pregnant. Patients with no acceptance of use of effective contraception during and at least 70 days after study participation. 4) Past history of usage of peptides employed in the study. 5) Patients who are judged inappropriate for enrollmwnt in this study by the attending doctors.

Design outcomes

Primary

Measure	Time frame
Evaluation of immunological responses (anti-peptide IgG) before and after 4 doses of vaccination	—

Secondary

Measure	Time frame
Adverse events and safety of personalized peptide vaccination evaluated by 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.jp0942-31-7744

Outcome results

None listed

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