NIPH Clinical Trials Search

UMIN ID: UMIN000001821

Registered date:31/03/2009

Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against recurrent prostate cancer: A phase I/II study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedProstate cancer
Date of first enrollment2009/03/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. The administration interval is essentially every week.


Primary OutcomeEvaluation of side effects (phase I) Progression-free survival (phase II)
Secondary OutcomeDisease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
Include criteria
Exclude criteriaThe following patients must be excluded: 1) Patients with uncontrollable infectious disease (including active Tuberculosis). 2) Patients with severe symptoms (malignant hypertension, severe congestive heart failure, severe colonary insufficiency, Myocardial Infarction within three months lately, terminal phase liver cirrhosis, uncontrollable Diabetes Mellitus, severe Pulmonary Fibrosis, active interstitial pneumonia, etc.). 3) Patients previously treated with Allogeneic bone marrow transplantation. 4) Patients with severe psychiatric disease. 5) Patients who participate in any other clinical trial. 6) Patients who previously participated in this clinical trial. 7) Any patients disqualified by a study physician because of medical, psychological, or any other factors.

Related Information


public contact
Address Japan
Affiliation Kitajima Hospital Department of Urolog
scientific contact
Name Kiyoaki Kitajima
Address 1662 Ochi-koh, Ochi-cho, Takaoka-gun, Kochi Japan
Affiliation Kitajima Hospital Department of Urology