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Phase I study of personalized peptide vaccination with transdermal adjuvant for cancer patients

Phase I study of personalized peptide vaccination with transdermal adjuvant for cancer patients - Phase I study of personalized peptide vaccination with transdermal adjuvant

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030854
Enrollment
10
Registered
2018-01-18
Start date
2016-04-01
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

WHSC2-103 peptide is intradermaly injected and subsequently Hisamitsu adjuvant LA3% is pasted. The patient also received personalized peptide vaccin formula with Montanide ISA51VG. The vaccins are adm

Sponsors

Kurume University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient meets all of the followings: 1) malignat tumor 2) more than 4-weeks past after the previous molecular targetting or chemotherapy 3) Performance status 0 or 1 4) HLA-A2 positive 5) IgG reactive to WHSC2-103 is positive and at least one more posiitive of vaccine panel peptides 6) expected life is more than 3 months 7) WBC more than 2,500/mm3 Lymphocyte more than 900/mm3 Hemoglobin more than 8.0 g/dL Platelet more than 50,000/mm3 Creatinin less than 2.0mg/dL Total bilirubin less than 2.5mg/dL 8) age more than 20 years old 9) acquisition of informed consent

Exclusion criteria

Exclusion criteria: Patient meets the followings: 1) under or have a plan of treatment with molecular tagetting or chemotherapy during this study 2) other severe diseases 3) severe allagic dideases 4) sensitive to adhesive plaster 5) woman with plegnancy or under milk feeding, man who is not accept contaception 6) doctor consider who is not appropriate for this study

Design outcomes

Primary

MeasureTime frame
Assessment of adeverse events using CTCAE v.4.0

Secondary

MeasureTime frame
Peptide-specigic IgG and CTL response after 6th vaccination

Countries

Japan

Contacts

Public Contactnot specified

Kurume University Cancer vaccine center

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

Outcome results

None listed

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