UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005819 |
|---|---|
| Receipt number | R000006881 |
| Scientific Title | Phase II clinical study of HLA-A*2402-restricted survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer |
| Date of disclosure of the study information | 2011/06/21 |
| Last modified on | 2015/12/21 17:39:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II clinical study of HLA-A*2402-restricted survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer
Acronym
Phase II study of survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer
Scientific Title
Phase II clinical study of HLA-A*2402-restricted survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer
Scientific Title:Acronym
Phase II study of survivin-derived peptide vaccine therapy for patients with recurrent non-muscle-invasive bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prophylactic effect of survivin-derived peptide vaccination for patients with recurrent bladder cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recurrence-free survival
Key secondary outcomes
Induction of epitope-specific T cell immunity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
peptide vaccination
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathologically confirmed urothelial carcinoma
2) Ta or T1 N0 M0 bladder cancer
3) Survivin-expressing tumor
4) HLA-A*2402
5) ECOG PS (Performance Status) 0-3
6) No organ failure (WBC >= 3000 cells/mm3, Hemoglobin >= 8.0 g/d, Platelet >= 10x10e4/mm3, Serum creatinine <= 2.0, Total bilirubin <=1.5, AST and ALT <= 2 x ULN
7) No previous chemotherapy, immunotherapy or radiotherapy within a month
8) Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment
Key exclusion criteria
1) Coexistence of other malignancy
2) Immunodeficiency or history of splenectomy
3) Intake of steroids or immunosuppressants
4) Severe heart disease, active infection, coagulation disorder
5) Under anticoagulant therapy
6) Pregnant woman
7) Lactating woman
8) Hope to have a children
9) No willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
10) History of severe drug allergy
11) History of severe drug-induced hepatic or renal dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Maeda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
maeda-t@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Maeda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
Homepage URL
maeda-t@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
札幌医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 21 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006881
