UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001359 |
|---|---|
| Receipt number | R000001656 |
| Scientific Title | Vaccination trial to synovial sarcoma patients using HLA-A24 restricted SYT-SSX junction peptide, adjuvant, and HLA-A24 anchor substituted peptide |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2014/05/13 13:52:16 |
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Basic information
Public title
Vaccination trial to synovial sarcoma patients using HLA-A24 restricted SYT-SSX
junction peptide, adjuvant, and HLA-A24 anchor substituted peptide
Acronym
Peptide vaccination to synovial sarcoma
Scientific Title
Vaccination trial to synovial sarcoma patients using HLA-A24 restricted SYT-SSX
junction peptide, adjuvant, and HLA-A24 anchor substituted peptide
Scientific Title:Acronym
Peptide vaccination to synovial sarcoma
Region
| Japan |
Condition
Condition
synovial sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To comfirm safety and efficacy of SYT-SSX junction peptide to desseminated synovial sarcoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Toxicity and adverse effect between first vaccination and 2 weeks after 6th vaccination.
Key secondary outcomes
delayed type hypersesitivity, frequency of T lymphocyte responsive to HLA-A24 restricted peptide, cytotoxic T-lymphocyte acitivity, anti-tumor effect
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
Total 6 times, every two weeks vaccination including 1mg of peptide and adjuvant.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
histologically and genetically (SYT-SSX 1 or SYT-SSX 2 positive) confirmed, unresectable synovial sarcoma, HLA-A2402 positive, between 20 and 70 years old, ECOG performance status between 0 and 3, informed consent
Key exclusion criteria
prior chemotherapy, steroid therapy, or other immunotherapy within the past 4 weeks, presence of other cancers, immunodefficiency, history of splenectomy, severe cardiac insufficiency, acute infection, hematopoietic failure , anti-coagulant therapy
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuro Wada |
Organization
Sapporo Medical University
Division name
Orthopaedic Surgery
Zip code
Address
South 1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Wada |
Organization
Sapporo Medical University
Division name
Orthopaedic Surgery
Zip code
Address
South 1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Socieity for Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Musculoskeletal Oncology Group
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
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/j.1349-7006.2012.02370.x/full
Number of participants that the trial has enrolled
Results
Twelve-one patients were included in the study currently. One patient had a cerebral hemorrage as a serious adversed effect, which has already been reported to Ministry of Health, Labour, and Welfair. Seven of 21 patients were evaluated as stable disease. Fourteen patients were evaluated as progressive disease.
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
| 2004 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 08 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001656
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
