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

UMIN ID: UMIN000001906

Registered date:25/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Head and Neck Tumor
• Date of first enrollment: 2009/04/01
• Target sample size: 65
• 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. 24 weekly immunizations are planned.

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: 15years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: The 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

• Primary Sponsor: Anti-tumor Immunotherapy Research Network, Department of Immunology, Kochi Medical School
• Source(s) of Monetary Support: Research fund from the Kochi Univ.