NIPH Clinical Trials Search

UMIN ID: UMIN000001854

Registered date:10/04/2009

Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer failed to standard treatment

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUrotherial cancer
Date of first enrollment2009/04/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)(1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide). Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 45: Final evaluation. The 1st treatment (total 6 times, every weeks) is finished.


Primary OutcomeEvaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
Secondary Outcome1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.

Related Information


public contact
Name Akira Yamada
Address Asahi-machi 67, Kurume, Japan
Telephone 0942-31-7744
Affiliation Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
scientific contact
Name Masanori Noguchi
Address Asahi-machi 67, Kurume, Japan
Telephone 0942-31-7989
Affiliation Kurume University Research Center for Innovative Cancer Therapy, Division of Clinical Research