UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005859 |
|---|---|
| Receipt number | R000006925 |
| Scientific Title | Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Combined with IFA and IFN-alpha for Patients with Urothelial Cancer (Phase I clinical study) |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2014/03/03 08:40:15 |
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Basic information
Public title
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Combined with IFA and IFN-alpha for Patients with Urothelial Cancer (Phase I clinical study)
Acronym
Phase I clinical study of Survivin-2B peptide vaccination combined with IFA and IFN -alpha for urothelial cancer
Scientific Title
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Combined with IFA and IFN-alpha for Patients with Urothelial Cancer (Phase I clinical study)
Scientific Title:Acronym
Phase I clinical study of Survivin-2B peptide vaccination combined with IFA and IFN -alpha for urothelial cancer
Region
| Japan |
Condition
Condition
Advanced or recurrent urothelial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and investigation of anti-tumor effect of survivin-2B peptide combined with IFA and IFN-alpha against patients with urothelial cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of adverse effect
Key secondary outcomes
Evaluation of immunological and clinical responses. Immunological responses are investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses are evaluated by RECIST criteria.
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
| Medicine | Vaccine |
Interventions/Control_1
Survivin-2B peptide vaccination at a dose of 1.0mg once and IFN-alpha at a dose of 300 million-unit twice every 2 weeks
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
Patients enrolled in this study were required to conform to the following criteria: (1) to have histologically confirmed urothelial cancer, (2) to be HLA-A*2402 positive, (3) to be survivin- and HLA class I-positive in the carcinomatous lesions by immunohistochemistry, (4) to be between 20 and 85 years old, (5) to have received of surgical excision of the primary tumor and (6) to have Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3.
Key exclusion criteria
Exclusion criteria included (1) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the previous 4 weeks, (2) the presence of other cancers that might influence the prognosis, (3) immunodeficiency or a history of splenectomy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure and (5) unsuitability for the trial based on clinical judgment.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitamura |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
Address
South-1, West-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
hkitamu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Tanaka |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
Address
South-1, West-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
zappa@pop12.odn.ne.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Corporation Innovation Plaza Hokkaido, Sapporo, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Pathology, Sapporo Medical University School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://dx.doi.org/10.1155/2013/262967
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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2014 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006925
