UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001632 |
|---|---|
| Receipt number | 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 13:25:05 |
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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
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
twada@sapmed.ac.jp
Sponsor or person
Institute
Dept Orthopaedic Surgery, Sapporo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001961
