UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001906 |
|---|---|
| Receipt number | 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 11:34:46 |
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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
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
vaccine@kochi-u.ac.jp
Sponsor or person
Institute
Anti-tumor Immunotherapy Research Network, Department of Immunology,
Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002317
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