NIPH Clinical Trials Search

UMIN ID: UMIN000001061

Registered date:10/03/2008

Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUrotherial cancer
Date of first enrollment2008/03/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)(1st treatment:total 12 times, every week) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide). Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 85: Final evaluation. The 1st treatment (total 12 times, every week) is finished, but the 2nd treatment would be continued according to the patient's request. The schedule will be determined based on the reactivity to peptides. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be changed.


Primary OutcomeEvaluation (clinical responses) of anti-tumor effects of peptide vaccination.
Secondary Outcome1.Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination. 2.Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet. Evaluation of long-term prognosis (progression free survival and total survival). 3.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 maximum85years-old
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 multiple cancers 3) Patients with the past history of severe allergic reactions. 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 0942-31-7572
Affiliation Kurume University School of Medicine Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
scientific contact
Name Nasanori Noguchi
Address asahi-machi 67, Kurume, Japan
Telephone 0942-31-7572
Affiliation Kurume University School of Medicine Department of Urology