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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001632
Receipt No. R000001961
Scientific Title Vaccination trial with the PBF-derived peptide in HLA-A2+ patients with osteosarcoma
Date of disclosure of the study information 2009/01/14
Last modified on 2012/01/16

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Basic information
Public title Vaccination trial with the PBF-derived peptide in HLA-A2+ patients with osteosarcoma
Acronym Vaccination trial with the PBF-derived peptide in HLA-A2+ patients with osteosarcoma
Scientific Title Vaccination trial with the PBF-derived peptide in HLA-A2+ patients with osteosarcoma
Scientific Title:Acronym Vaccination trial with the PBF-derived peptide in HLA-A2+ patients with osteosarcoma
Region
Japan

Condition
Condition osteosarcoma
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Confirmation of the safety of PBF-derived peptide vaccination for HLA-A2+ patients with osteosarcoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Toxicity, immunological response, anti-tumor effects
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 HLA-A2-restricted PBF peptide(ALPSFQIPV) 1mg
IFA
Interventions/Control_2 HLA-A2-restricted PBF peptide(ALPSFQIPV) 10mg
+IFA
Interventions/Control_3 HLA-A2-restricted PBF peptide(ALPSFQIPV) 1mg
+IFA
+Interferon alpha
Interventions/Control_4 HLA-A2-restricted PBF peptide(ALPSFQIPV) 10mg
+IFA
+Interferon alpha
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Eligible patients are those (i) who have histologically confirmed unresectable osteosarcoma, (ii) who have PBF positive in tumor (assessed by RT-PCR or IHC), (iii) HLA-A*0201 positive, (iv) non-responder to chemotherapy or who could not receive further chemotherapy (iii) between 10 and 70 years old, (iv) ECOG performance status between 0 and 3, and (v) who gave informed consent.
Key exclusion criteria Exclusion criteria included (i) prior chemotherapy, steroid therapy, or other immunotherapy within the past 4 weeks, (ii) presence of severe organ failure or other cancers that might influence the prognosis, (iii) immunodeficiency or a history of splenectomy, (iv) severe cardiac insufficiency, acute infection, or hematopoietic failure, (v) pregnany or ongoing breast-feeding, (vi) unsuitability for the trial based on the clinical judgment of the doctors involved.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuro Wada
Organization Sapporo Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address South-1, West-16, Chuo-ku, Sapporo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuro Wada
Organization Sapporo Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
Email twada@sapmed.ac.jp

Sponsor
Institute Dept Orthopaedic Surgery, Sapporo Medical University
Institute
Department

Funding Source
Organization Grants-in-Aid from MEXT, the Ministry of Health, Labor and Welfare.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Dept Pathology, Sapporo Medical University
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
2009 Year 01 Month 14 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
2008 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 14 Day
Last modified on
2012 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001961

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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