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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001906
Receipt No. R000002317
Scientific Title Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against Head and Neck Tumor: A phase I/II study
Date of disclosure of the study information 2009/04/25
Last modified on 2019/07/01

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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/ctr_e/ctr_view.cgi?recptno=R000002317

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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