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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011029
Receipt No. R000012893
Scientific Title Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer
Date of disclosure of the study information 2013/07/01
Last modified on 2019/12/29

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Basic information
Public title Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer
Acronym Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer
Scientific Title Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer
Scientific Title:Acronym Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer
Region
Japan

Condition
Condition Lung, breast, pancreas, stomach, and colorectal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 <Phase I portion>
To assess the safety and feasibility of WT1 peptide vaccination with adjuvant OK-432.
<Phase II portion>
To assess the efficacy of WT1 peptide vaccination with adjuvant OK-432.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes <Phase I portion>
Ratios of adverse events
<Phase II portion>
PFS: Progression free survival, Overall survival
Key secondary outcomes <Phase I portion>
WT1 specific CTL rate in peripheral blood mononuclear cells (PBMCs), Lymphocyte subsets, WT1-specific interferon(IFN)-gamma production of PBMCs
<Phase II portion>
The ratio of the patients who completed the course, WT1 specific CTL rate in PBMCs, Lymphocyte subsets, WT1-specific IFN-gamma production of PBMCs

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
Vaccine
Interventions/Control_1 Seven doses of HLA-A*24-restricted WT1 peptide (3 mg) emulsified with 1-2KE of OK-432 adjuvant will be intradermally injected on bilateral axillary and inguinal areas every 2 weeks. Injection schedule can be changed within 3 days.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with pathologically proven breast, lung, pancreas, stomach, or colorectal cancer.
2. Patients treated with operation, chemotherapy, and radiotherapy accoding to standard clinical guidelines.
3. Patients who did not received any specific immunotherapy before enrollment of this trial.
4. Patients enrolled the trial of WT1 pulsed dendritic cell therapy, but excluded due to the criteria of leukapheresis.
5. Patients with HLA-A*24 and having neither allergies to OK-432 nor to penicillin.
6. Patients aged 20 years or over at the time of informed concent.
7. Karnofsky performance status (KPS) are over 60%.
8. Estimated survival duration is over 3 months.
9. Function of major organs is maintained, with the following inclusion criteria.
A) Leukocyte count>=3,000/mm3
B) Lymphocyte count>=500/ mm3
C) Platelet count>=100,000/mm3
D) Hemoglobin concentration >=10.0g/dL
E) AST/ALT <2.5 x ULN
F) Serum creatinine <=1.5 x ULN
G) APTT/PT-INR <=1.5 x ULN
Key exclusion criteria 1. Patients with severe organ dysfunction, infection under treatment, blood abnormalities or bleeding tendency.
2. Patients fulfilling the criteria of WT1 pulsed dendritic cell therapy are excluded from this trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shigetaka
Middle name
Last name Shimodaira
Organization Shinshu University Hospital
Division name Center for Advanced Cellular Therapy
Zip code 390-8621
Address Asahi 3-1-1 Matsumoto city,Japan, 390-8621
TEL 0263-37-3220
Email shimodai@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Shigetaka
Middle name
Last name Shimodaira
Organization Shinshu University Hospital
Division name Center for Advanced Cellular Therapy
Zip code 390-8621
Address Asahi 3-1-1 Matsumoto city,Japan, 390-8621
TEL 0263-37-3220
Homepage URL
Email shimodai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Division of Dendritic Cell therapy, Matsumoto Dental University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinshu University Ethics committee
Address Asahi 3-1-1 Matsumoto city, Japan, 390-8621
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 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 No longer recruiting
Date of protocol fixation
2013 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 24 Day
Last modified on
2019 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012893

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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