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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001359
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Sapporo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001656

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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