A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression

A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression - A phase II trial of peptide vaccination for several cancer patients with slight bone marrow suppression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019390

Enrollment

1000

Registered

2015-10-19

Start date

2015-10-19

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

Cancer patients who are under standard treatments or resistant to standard treatments with slight bone marrow suppression

Interventions

4 peptide vaccines are selected from 31 peptide restrcted by HLA-class I based on higher peptide-specific IgG responses before vaccination. Selected peptides are separately and subcutaneously injecte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients who are during or resistant to standard treatment of Prostate, Urothelium, Kidney, Brain, Head and Neck, Lung, Esophagus, Stomach, Liver, Biliary tract, Pancreas, Colon, Ovary, Uterus, Breast, Sarcoma, Hematapostema, Skin, Primary unknown cancer and Rare cancer. 2)Patients must be at a score level of 0-2 of performance status(PS)(ECOG). 3)Patients must have IgGs reactive to at least 2 peptides from 31 candidate peptides restricted to the patient's HLA types. 4)Patients must be expected to survive more than 3 months. 5)Patient's laboratory data must satisfy the followings: WBC > and = 2000/mm3 Lymphocyte 500-900/mm3 Hb > and = 8.0 g/dL Platelet > and = 50000/mm3 Serum Creatinine < and = 2.0mg/dL Serum Total Bilirubin < and = 2.5mg/dL 6)Patients must be more 18 years-old. 7)Written informed consent must be obtained from patients. 8)Patients must be positive for HLA-A2,A24,A26,A3,A11,A31,A33

Exclusion criteria

Exclusion criteria: The following patients must be excluded. 1)Patients with severe underlying diseases/ conditions(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc.) 2)Patients with the past history of severe allergic reactions. 3)(Females) Pregnant or nursing patients. Patients desiring future fertility. (Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 4)Patients who are judged inappropriate for entry to this clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Assessment of immunoresponses by mesurement of peptide specific IgGs	—

Secondary

Measure	Time frame
1.Safety assessment 2.Overall survival	—

Countries

Japan

Contacts

Public ContactShigeru Yutani

Kurume University Cancer Vaccine Center

yutani@med.kurume-u.ac.jp0942-27-5210

Outcome results

None listed

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