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

Not Applicable

• Conditions: Head and Neck Tumor

• Registration Number: JPRN-UMIN000001906
• Lead Sponsor: Anti-tumor Immunotherapy Research Network, Department of Immunology, Kochi Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-25
• Study Completion: 2015-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of side effects (phase I) Progression-free survival (phase II)

Secondary Outcome Measures

Name	Time	Method
Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses