UMIN-CTR Clinical Trial

Basic information
Public title	Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against Head and Neck Tumor: A phase I/II study
Acronym	An immunotherapy against Head and Neck Tumor
Scientific Title	Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against Head and Neck Tumor: A phase I/II study
Scientific Title:Acronym	An immunotherapy against Head and Neck Tumor
Region	Japan

Condition
Condition	Head and Neck Tumor
Classification by specialty	Oto-rhino-laryngology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is undertaken to evaluate the safety and anti-tumor effects of an immunotherapy using WT1 peptide and pertussis whole cell vaccine against Head and Neck Tumor. Patients to be recruited must bear at least one copy of either HLA-A*02:01, A*02:06, A*02:07 or A*24:02 gene.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of side effects (phase I) Progression-free survival (phase II)
Key secondary outcomes	Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. 24 weekly immunizations are planned.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who have been histologically diagnosed to have one of the following head and neck tumors. adenocarcinoma, adenoid cystic carcinoma, malignant melanoma, sarcoma 2) Patients must bear at lease one copy of either HLA-A*24:02, A*02:01, A*02:06 or A*02:07 gene. 3) The tumor tissue is positive for WT1 expression by immunohistochemical staining. 4) Age 15 to 85 5) Karnofsky Index >= 60 (PS 0-2 by ECG) 6) Sufficient function of critical organs including heart, lung, liver, kidney and bone marrow needs to be maintained. Creatinin <= 3.0mg/dl BUN <= 25 mg/dl Total Bilirubin <= 1.5 mg/dl AST <= 105 U/l ALT <= 120 U/l Neutrophil >= 1,500/mm3 Platelet >= 75,000/mm3 Hemoglobin >= 8.0g/dl ECG: no serious irregularities PaO2 >= 70mmHg (room air) 7) Life expectancy should be three months or greater. 8) Patients without additional malignant diseases. 9) Written informed consents are obtained from patients after giving sufficient explanations and confirming their understandings about disease conditions.
Key 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.
Target sample size	65

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masamitsu Hyodo
Organization	Kochi Medical School
Division name	Department of Otorhinolaryngology
Zip code
Address	Kohasu, Okoh-cho, Nankoku, Kochi 783-8505, Japan.
TEL	088-880-2393
Email

Public contact
Name of contact person	1st name Middle name Last name Keiko Udaka
Organization	Kochi Medical School
Division name	Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Zip code
Address	Kohasu, Okoh-cho, Nankoku, Kochi 783-8505, Japan.
TEL	088-880-2318
Homepage URL
Email	vaccine@kochi-u.ac.jp

Sponsor
Institute	Anti-tumor Immunotherapy Research Network, Department of Immunology, Kochi Medical School
Institute
Department

Funding Source
Organization	Research fund from the Kochi Univ.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	高知大学医学部附属病院（高知県） 名古屋市立大学医学部附属病院（愛知県） 島根大学医学部附属病院（島根県）

Other administrative information
Date of disclosure of the study information	2009 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 27 Day
Date of IRB	2009 Year 03 Month 24 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 04 Month 25 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002317