Randomized Phase II clinical trial of personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients.

Randomized Phase II clinical trial of personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients. - Randomized Phase II clinical of personalized peptide vaccination for standard therapy failed Biliary cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006249

Enrollment

Registered

2011-08-30

Start date

2011-09-01

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

Biliary cancer

Interventions

A:Personalized peptide vaccination with low dose of cyclophosphamide treatment. The cyclophosphamide of the low dosage (100mg / day) is administered for seven days before the day of tha peptide vacci

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients with standard therapy failed Biliary cancer. Presence of target legion is not considered. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings. WBC is more than 2500 per mm3 Lymphocyte is more than 1000 per mm3 Hb is more than 8.0 g per dL Platelet is more than 50000 per mm3 Serum creatinine is less than 2.0mg per dL Total bilirubin is less than 2.5mg per dL 6) Patients must be more than 20 years old. 7) Written informed consent must be obtained from patients. 8) PatientsPatients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

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) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) 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. 5)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.

Design outcomes

Primary

Measure	Time frame
Number of immuno-regulatory cells.	—

Secondary

Measure	Time frame
1. overall survival 2.Evaluation of immune responses (anti-peptide IgG,CTL). 3.Adverse effects of peptide vaccination safety of the protocol is evaluated based on the NCI-CTCAE.	—

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