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A phase II continuous clinical trial of peptide vaccination for cancer patients

A phase II continuous clinical trial of personalized peptide vaccination for cancer patients - A phase II continuous clinical trial of peptide vaccination for cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071180058
Enrollment
200
Registered
2019-03-19
Start date
2008-11-06
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

Select vaccine peptides (up to 4) from 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously inje

Sponsors

Yutani Shigeru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Following the acceptance criteria of the currently conducted 45 tests Show a common reference to the following. Common items are shown below 1) Patients must be more 6 years old 2) Patients must be at a score level 0 to 2 of ECOG perfformance status. 3) Written informed consent must be obtained from patients. Both the assent document and the written informed consent must be obtained from a patient and his (her) parents or caregivers when a patient is with >=6 years to <20 years old.It is possible to obtained the written informed consent from either the parents or an attorney if a patient is difficult to sign to it due to neurological or physical symptoms.

Exclusion criteria

Exclusion criteria: Exclusion criteria also follow exclusion criteria of 45 studies currently being conducted 1) Patients with severe symptoms(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disease of coagulation) 2) Patients with the past history of severe allergic reactions. 3) (Females) Patienta who are during pregnancy, latation expectant and desiring future fertility. (Males) Patients do not accept contraception during the last 70 days after the last vaccination. 4) Patient who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

MeasureTime frame
Analysis of correlation between peptide-specific antibody level and overall survival

Secondary

MeasureTime frame
1) Analysis of correlation between CTL responses and overall survival 2) Evaluation of adverse events by CTCAE version 4.0 (JCOG)

Countries

Japan, No Country

Contacts

Public ContactShigeru Yutani

Kurume University

yutani@med.kurume-u.ac.jp+81-942-27-5210

Outcome results

None listed

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