UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011029 |
|---|---|
| Receipt number | 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 | 2023/12/27 18:52:20 |
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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
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
shimodai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 30 | Day |
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
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012893
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