A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients

A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients - A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014855

Enrollment

200

Registered

2014-08-14

Start date

2014-08-14

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

Rare cancer or primary unknown cancer

Interventions

Personalized peptide vaccination are selected from 31 peptides restricted on higher peptide-specific IgG responses before vaccination. Selected peptides are separately and subcutaneously injected(3.0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be diagnosed as malignant tumor and divided into rare cancer or primary unknown cancer. However, we don't make conditions that have evaluational lesion or clinical stage. 2)Patients must be at a score level of 0-1 of performance status(PS)(ECOG). 3)Patients must have IgG reactive to at least 2 peptides from 31 peptides restricted by HLA-class I. 4)Patients must be expected to survive more than 3 months. 5)Patients must satisfy the followings: WBC >and= 2500/mm3 Lymphocyte >and= 1000/mm3 Hb >and= 8.0g/dL Plt.>and= 80000/mm3 Serum Creatinine < and= 2.0 x upper limit of normal Total Bilirubin < and= 2.0 x upper limit of normal 6)Patients must be more 18 year-old. 7)Written informed consent must be obtained from patients. 8)Patients must be positive for HLA-class I (-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 and disturbance of coagulation). 2)Patients with the past history of severe allergic reactions. 3)(Female) Patients who are pregnancy,lactation and hope the graviditas. (male) Patient who do not agree prevebt pregnancy. 4)Patients who are judged inappropriate for entry to this clinical trial by doctor in charge.

Design outcomes

Primary

Measure	Time frame
Assesment of immunoresponses by measurement of peptide-specific IgGs and CTL responses by ELISPOT assay.	—

Secondary

Measure	Time frame
1. Analyze of correlation between immunological responses and overall survival. 2. Safety assessment	—

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