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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004911
Receipt No. R000005848
Scientific Title Phase I clinical trial of epitope peptides based vaccines targeting VEGFR1 in patients with advanced renal cell carcinoma
Date of disclosure of the study information 2011/01/20
Last modified on 2013/07/24

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Basic information
Public title Phase I clinical trial of epitope peptides based vaccines targeting VEGFR1 in patients with advanced renal cell carcinoma
Acronym Phase I clincal trial of epitope peptides based vaccines targeting VEGFR1 in patients with advanced renal cell carcinoma
Scientific Title Phase I clinical trial of epitope peptides based vaccines targeting VEGFR1 in patients with advanced renal cell carcinoma
Scientific Title:Acronym Phase I clincal trial of epitope peptides based vaccines targeting VEGFR1 in patients with advanced renal cell carcinoma
Region
Japan

Condition
Condition advanced renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
Key secondary outcomes

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 Vaccination using epitope peptide
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Performance status 0-2
HLA-A2 and/or -A24
No responce to (IL-2, IFN, sorafenib, sunitinib) etc
Key exclusion criteria pregnancy
uncontroled infection
uncontroled cerebral metastasis
etc
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uemura Hirotsugu
Organization Kinki University School of Medicine
Division name Urology
Zip code
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine
Division name Urology
Zip code
Address
TEL
Homepage URL
Email huemura@med.kindai.ac.jp

Sponsor
Institute Department of Urology, Kinki University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 近畿大学医学部付属病院 Kinki University School of Medicine Hostipal

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2007 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information K Yoshimura, T Minami, M Nozawa and H Uemura

Phase I clinical trial of human vascular
endothelial growth factor receptor 1 peptide vaccines for patients with metastatic renal cell carcinoma

British Journal of Cancer (2013)

Management information
Registered date
2011 Year 01 Month 20 Day
Last modified on
2013 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005848

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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