A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.

A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes. - Metoformin addition combination phase II clinical trial for the personalized peptide vaccine resistant patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020306

Enrollment

150

Registered

2015-12-24

Start date

2015-12-24

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

The patients whom a symptom aggravates without being complicated with diabetes of various personalized peptide vaccine phase II trial entries.

Interventions

For the patients who were enrolled personalized peptide vaccination and judged as exacerbation at the end of 1st course of clincal trial, add metoformin 500mg/Day on peptide vaccination.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients who is not complicated with diabetes and HbA1c level is less than 6.5% 2)Patient who were enrolled personalized peptide vaccination and judged as exacerbation at the end of 1st course of clincal trial. 3)Patients must be a at a score level 0-2 of ECOG performance status. 4)Patients must have IgGs reactive to at least 2 of the candidate peptides restricted to the patient's HLA types. 5)Patients must be excepted to survive more than 3 months. 6)Patients must satisfy the followings: WBC >and= 2500/mm3 Lymphocyte >and= 900/mm3 Hb >and= 8.0g/dL Platelet >and= 50000/mm3 Serum Creatinine <and= 2.0mg/dL Total Bilirubin <and= 2.5mg/dL 7)Patients must be more 18 years-old. 8)Written informed consent must be obtained from patients. 9)patients must be positive for HLA-class I A(-2,-24,-26,-3,-11,-31 or -33).

Exclusion criteria

Exclusion criteria: The following patients must be excluded. 1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, et al.) 2)Patients with the past history of severe allergic reactions. 3)(Female)Pregnant or nursing patients. (Male)Patients who do not accept contraception from the 1st vaccination to 70 days after last vaccination. 4)Patients who are judjed inappropriate for entry to this clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Assesment of immunoresponses by mesuremant of peptide specific IgGs before and after peptide vaccination with metformin.	—

Secondary

Measure	Time frame
Safety assessments Clinical response(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