NIPH Clinical Trials Search

UMIN ID: UMIN000001906

Registered date:25/04/2009

Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against Head and Neck Tumor: A phase I/II study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHead and Neck Tumor
Date of first enrollment2009/04/01
Target sample size65
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. 24 weekly immunizations are planned.


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 minimum15years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteriaThe following patients must be excluded: 1) Patients with uncontrollable infectious diseases (including active Tuberculosis). 2) Patients with severe complications(malignant hypertension, severe congestive heart failure, severe colonary insufficiency, Myocardial Infarction within three months, terminal stage of liver cirrhosis, uncontrollable Diabetes Mellitus, severe Pulmonary Fibrosis, active interstitial pneumonitis, etc.). 3) Patients after allogeneic bone marrow transplantation. 4) Pregnant or breast-feeding women. 5) Patients with severe psychiatric diseases. 6) Patients who have participate in any other clinical trial. 7) Patients who have previously participated in this clinical trial. 8) Any patients disqualified by a study physician because of medical, psychological, or any other reason.

Related Information


public contact
Name Keiko Udaka
Address Kohasu, Okoh-cho, Nankoku, Kochi 783-8505, Japan. Japan
Telephone 088-880-2318
Affiliation Kochi Medical School Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
scientific contact
Name Masamitsu Hyodo
Address Kohasu, Okoh-cho, Nankoku, Kochi 783-8505, Japan. Japan
Telephone 088-880-2393
Affiliation Kochi Medical School Department of Otorhinolaryngology