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

UMIN ID: UMIN000001821

Registered date:31/03/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Evaluation of side effects (phase I) Progression-free survival (phase II)
• Secondary Outcome: Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: The 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

• Primary Sponsor: Department of Immunology, Kochi University School of Medicine
• Source(s) of Monetary Support: Japan Science and Technology Agency